Atlas FDA

VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM

FDA 510(k) clearance K080107 · decided 2008-02-28

Clearance details

K-number
K080107
Device name
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
Applicant
bioMerieux, Inc.
Decision
Substantially Equivalent
Date received
2008-01-15
Decision date
2008-02-28
Days to decision
44 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hazelwood, MO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch bioMerieux

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)bioMerieux, Inc.2026-04-15
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)BIOMERIEUX2026-03-26
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)bioMerieux, Inc.2025-08-21
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713)Becton, Dickinson and Company2025-08-08
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447)Becton, Dickinson and Company2025-05-19
VITEK COMPACT PRO (K234012)bioMerieux, Inc.2025-03-14
BD Phoenix™ Automated Microbiology System (K250344)Becton, Dickinson and Company2025-03-06
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986)Becton, Dickinson and Company2024-03-15
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
Colibrí (K232756)Copan Wasp Srl2023-12-27
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201)bioMerieux, Inc.2023-10-23
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864)bioMerieux, Inc.2023-07-05

Recalls involving this device

RecordFirmDate
VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic recall (Z-2049-2011)Biomerieux Inc2011-04-27
VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic recall (Z-2050-2011)Biomerieux Inc2011-04-27
VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For In Vitro Diagnostic U recall (Z-0172-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN23, REF 22 228, For In Vitro Diagnostic U recall (Z-0173-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN24, REF 22 229, For In Vitro Diagnostic U recall (Z-0174-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN25, REF 22 230, For In Vitro Diagnostic U recall (Z-0175-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro Diagnostic U recall (Z-0176-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN27, REF 22 245, For In Vitro Diagnostic U recall (Z-0177-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN28, REF 22 254, For In Vitro Diagnostic U recall (Z-0178-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN29, REF 22 266, For In Vitro Diagnostic U recall (Z-0179-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN30, REF 22 267, For In Vitro Diagnostic U recall (Z-0180-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN31, REF 22 268, For In Vitro Diagnostic U recall (Z-0181-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN32, REF 22 269, For In Vitro Diagnostic U recall (Z-0182-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN33, REF 22 270, For In Vitro Diagnostic U recall (Z-0183-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN34, REF 22 271, For In Vitro Diagnostic U recall (Z-0184-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic U recall (Z-0185-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN36, REF 22 300, For In Vitro Diagnostic U recall (Z-0186-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN37, REF 22 312, For In Vitro Diagnostic U recall (Z-0187-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN39, REF 22 337, For In Vitro Diagnostic U recall (Z-0188-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN41, REF 410 757, For In Vitro Diagnostic recall (Z-0189-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN42, REF 410 758, For In Vitro Diagnostic recall (Z-0190-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N080, REF 22 214, For In Vitro Diagnostic U recall (Z-0191-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N081, REF 22 215, For In Vitro Diagnostic U recall (Z-0192-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N082, REF 22 217, For In Vitro Diagnostic U recall (Z-0193-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N084, REF 22 224, For In Vitro Diagnostic U recall (Z-0194-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N085, REF 22 225, For In Vitro Diagnostic U recall (Z-0195-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For In Vitro Diagnostic U recall (Z-0196-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N087, REF 22 235, For In Vitro Diagnostic U recall (Z-0197-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N088, REF 22 236, For In Vitro Diagnostic U recall (Z-0198-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N089, REF 22 237, For In Vitro Diagnostic U recall (Z-0199-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For In Vitro Diagnostic U recall (Z-0200-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N091, REF 22 241, For In Vitro Diagnostic U recall (Z-0201-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 243, For In Vitro Diagnostic U recall (Z-0202-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 246, For In Vitro Diagnostic U recall (Z-0203-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N094, REF 22 247, For In Vitro Diagnostic U recall (Z-0204-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N095, REF 22 249, For In Vitro Diagnostic U recall (Z-0205-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N096, REF 22 250, For In Vitro Diagnostic U recall (Z-0206-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N097, REF 22 251, For In Vitro Diagnostic U recall (Z-0207-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N098, REF 22 253, For In Vitro Diagnostic U recall (Z-0208-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N100, REF 22 256, For In Vitro Diagnostic U recall (Z-0209-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N103, REF 22 259, For In Vitro Diagnostic U recall (Z-0210-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N104, REF 22 261, For In Vitro Diagnostic U recall (Z-0211-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N105, REF 22 262, For In Vitro Diagnostic U recall (Z-0212-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N106, REF 22 264, For In Vitro Diagnostic U recall (Z-0213-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N108, REF 22 272, For In Vitro Diagnostic U recall (Z-0214-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N109, REF 22 273, For In Vitro Diagnostic U recall (Z-0215-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N110, REF 22 274, For In Vitro Diagnostic U recall (Z-0216-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N111, REF 22 275, For In Vitro Diagnostic U recall (Z-0217-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N112, REF 22 281, For In Vitro Diagnostic U recall (Z-0218-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N114, REF 22 283, For In Vitro Diagnostic U recall (Z-0219-2011)Biomerieux Inc2010-11-11

PMA approvals by this applicant

RecordFirmDate
THXID™-BRAF (P120014/S012)bioMerieux, Inc.2021-12-20
THxID-BRAF kit (P120014/S011)bioMerieux, Inc.2021-03-10
THxID-BRAF assay kit (P120014/S010)bioMerieux, Inc.2020-02-26
THxID BRAF assay kit (P120014/S009)bioMerieux, Inc.2019-08-26
THxID BRAF assay kit (P120014/S008)bioMerieux, Inc.2018-06-27
THxID-BRAF kit (P120014/S007)bioMerieux, Inc.2016-11-22
VIDAS TOTAL PSA (P040008/S013)bioMerieux, Inc.2016-05-31
THXID-BRAF KIT (P120014/S006)bioMerieux, Inc.2016-04-05