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
1921–1944 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
bioMerieux, Inc.
Microbiology · 52d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Aug 01, 2002
HERPESELECT 2 ELISA IGG, MODEL ELO920G
K021486 · MXJ
Focus Technologies, Inc.
Microbiology · 90d
Cleared Aug 01, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
K021954 · LON
Becton, Dickinson & CO
Microbiology · 48d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429 · MXJ
Focus Technologies, Inc.
Microbiology · 87d
Cleared Jul 25, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
K022129 · LON
Becton, Dickinson & CO
Microbiology · 24d
Cleared Jul 17, 2002
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020413 · LON
Dade Behring, Inc.
Microbiology · 160d
Cleared Jul 13, 2002
BACTEC MGIT 960 PZA KIT
K021582 · MJA
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jun 20, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184 · LTT
Dade Microscan, Inc.
Microbiology · 66d
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jun 17, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181 · JWY
Dade Microscan, Inc.
Microbiology · 63d
Cleared Jun 13, 2002
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K020706 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
K020707 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV V VCA IGM ELISA KIT MODEL# EBM-200
K020717 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 100d
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64...
K020410 · LON
Dade Behring, Inc.
Microbiology · 124d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
K021078 · LTT
Dade Microscan, Inc.
Microbiology · 64d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
K021110 · JWY
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111 · LTT
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSTREP PLUS PANEL, AZITHROMYCIN
K021169 · JWY
Dade Microscan, Inc.
Microbiology · 56d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
K021188 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Jun 06, 2002
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
K021445 · JWY
Ab Biodisk
Microbiology · 31d
Cleared Jun 04, 2002
PARACON II/FECAL CONCENTRATOR II
K021420 · LKS
Para Scientific Co.
Microbiology · 32d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938 · JWY
Dade Microscan, Inc.
Microbiology · 73d