Atlas FDA

VIDAS LYME SCREEN II

FDA 510(k) clearance K943812 · decided 1995-06-13

Clearance details

K-number
K943812
Device name
VIDAS LYME SCREEN II
Applicant
Biomerieux Vitek, Inc.
Decision
Substantially Equivalent
Date received
1994-08-05
Decision date
1995-06-13
Days to decision
312 days
Clearance type
Traditional
Product code
LSR
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Rockland, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x recall (Z-0316-04)Biomerieux, Inc.2004-07-20

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