FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1801–1824 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 19, 2003
PASCO MIC AND MIC/ID PANELS
K032259 · JWY
Bd Diagnostic Systems
Microbiology · 28d
Cleared Aug 18, 2003
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE...
K032131 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 13, 2003
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K032246 · JSM
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · LGD
Beckman Coulter, Inc.
Microbiology · 24d
Cleared Aug 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
K031943 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K031602 · LON
Dade Behring, Inc.
Microbiology · 71d
Cleared Jul 30, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K031699 · LON
Becton, Dickinson & CO
Microbiology · 58d
Cleared Jul 30, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
K031727 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE...
K031912 · LON
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 17, 2003
XPECT INFLUENZA A/B
K031565 · PSZ
Remel, Inc.
Microbiology · 59d
Cleared Jul 16, 2003
RUBELLACOL
K031490 · LQN
Immunostics Inc.,
Microbiology · 65d
Cleared Jul 16, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Jul 16, 2003
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
K031679 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jul 14, 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · MDB
bioMerieux, Inc.
Microbiology · 40d
Cleared Jul 14, 2003
ACON STREP A RAPID TEST DEVICE
K031784 · GTY
ACON Laboratories, Inc.
Microbiology · 34d
Cleared Jul 11, 2003
C. DIFF CHEK - 30
K030991 · LLH
Techlab, Inc.
Microbiology · 105d
Cleared Jul 11, 2003
C. DIFF CHEK - 60
K030992 · LLH
Techlab, Inc.
Microbiology · 105d
Cleared Jul 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
K031589 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Jul 10, 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
K031059 · MHJ
Ivd Research, Inc.
Microbiology · 104d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
bioMerieux, Inc.
Microbiology · 66d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · LON
Becton, Dickinson & CO
Microbiology · 56d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · NOP
Panbio Limited
Microbiology · 5d