Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1825–1848 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Aug 29, 2003
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 27, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Aug 22, 2003
VERSATREK
K032306 · MDB
Trek Diagnostic Systems, Inc.
Microbiology · 28d
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