Atlas FDA

BIOMERIEUX HEMOLAB AT III

FDA 510(k) clearance K934156 · decided 1994-12-22

Clearance details

K-number
K934156
Device name
BIOMERIEUX HEMOLAB AT III
Applicant
Biomerieux Vitek, Inc.
Decision
Substantially Equivalent
Date received
1993-08-27
Decision date
1994-12-22
Days to decision
482 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
Hazelwood, MO, US
Third-party review
No
Expedited review
No

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COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146)Biomerieux Vitek, Inc.2001-10-17
VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145)Biomerieux Vitek, Inc.2001-06-25
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144)Biomerieux Vitek, Inc.2001-06-13
VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142)Biomerieux Vitek, Inc.2001-05-30
VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141)Biomerieux Vitek, Inc.2001-05-14
VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140)Biomerieux Vitek, Inc.2001-03-09
VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138)Biomerieux Vitek, Inc.2000-08-11