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
5281–5304 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 14, 1985
PHARMACIA B2-MICRO EIA
K844469 · JZG
Pharmacia, Inc.
Microbiology · 87d
Cleared Feb 06, 1985
MICRO ORGANISM GROWTH SYS-M1000
K843000 · LIO
Hml Inc/Biotechnology Transfer
Microbiology · 191d
Cleared Feb 06, 1985
IMAGEN CHLAMYDIA TEST
K844683 · IWP
Boots-Celltech Diagnostics, Inc.
Microbiology · 68d
Cleared Feb 01, 1985
RAPID DIAGNOSTIC KIT
K844442 · LIB
Portable Medical Laboratories, Inc.
Microbiology · 77d
Cleared Jan 30, 1985
BIO-STAT III PLATE WASHER
K844552 · JTC
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared Jan 30, 1985
TITERTEK DULUTER/DISPENSER 78-640-00
K844568 · JTC
Flow Laboratories, Inc.
Microbiology · 68d
Cleared Jan 30, 1985
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
K844571 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 68d
Cleared Jan 30, 1985
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
K844634 · JSM
Precision Dynamics Corp.
Microbiology · 64d
Cleared Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
K842216 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 239d
Cleared Jan 29, 1985
CMV TEST
K843138 · LIN
Microbiological Research Corp.
Microbiology · 173d
Cleared Jan 25, 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jan 23, 1985
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
K844836 · GWD
Edward Weck, Inc.
Microbiology · 42d
Cleared Jan 22, 1985
TITERTEK MICROPLATE WASHER 120
K844500 · JTC
Flow Laboratories, Inc.
Microbiology · 63d
Cleared Jan 18, 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · GQL
Syva Co.
Microbiology · 303d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/DEXTROSE
K844542 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/LACTOSE
K844543 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/MALTOSE
K844544 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/MANNITOL
K844545 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/SUCROSE
K844546 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
K844547 · JSD
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
UREA AGAR
K844548 · JSH
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST
K844582 · LJP
Syncor Intl. Corp.
Microbiology · 54d
Cleared Jan 16, 1985
VENTRESCREEN STREP A TEST
K844855 · GTZ
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Jan 08, 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · KIR
Difco Laboratories, Inc.
Microbiology · 347d