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
4777–4800 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 13, 1986
MUREX SUDS RUBELLA
K861282 · LFX
Murex Corp.
Microbiology · 67d
Cleared Jun 13, 1986
MUREX SUDS TOXO
K861458 · LGD
Murex Corp.
Microbiology · 56d
Cleared Jun 13, 1986
MICROSCOPE SLIDES
K862112 · LIB
Abco Dealers, Inc.
Microbiology · 10d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631 · JXA
Syn-Kit, Inc.
Microbiology · 42d
Cleared Jun 10, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
K861997 · JSK
Hazleton Research Products, Inc.
Microbiology · 18d
Cleared Jun 05, 1986
TITERTEK MICROPLATE WASHER S-12
K862066 · JTC
Flow Laboratories, Inc.
Microbiology · 6d
Cleared Jun 04, 1986
RUBALEX (REVISED VERSION)
K861881 · LQN
Orion Corp.
Microbiology · 27d
Cleared Jun 03, 1986
DIRECTATEX STREP A
K861575 · GTY
Pacific Biotech, Inc.
Microbiology · 36d
Cleared Jun 03, 1986
HIPPURATE HYDROLYSIS TEST
K861888 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared Jun 03, 1986
D'ALA RAPID TEST
K861889 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared May 29, 1986
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
K861835 · GTH
Syva Co.
Microbiology · 16d
Cleared May 23, 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · LGD
Clinical Sciences, Inc.
Microbiology · 81d
Cleared May 20, 1986
VISIBLE-HERPES TM TEST SYSTEM
K854712 · GQO
Isolab, Inc.
Microbiology · 179d
Cleared May 20, 1986
CYTOTECH CMV IGG EIA
K860493 · GQI
Cytotech, Inc.
Microbiology · 99d
Cleared May 20, 1986
SENSITITRE AUTO ID PLATE, AP70
K861058 · JTO
Gibco Laboratories Life Technologies,...
Microbiology · 62d
Cleared May 20, 1986
QUADRA-TITER (TM) I.D. (MODIFICATION)
K861774 · JSS
Microtech Medical Systems, Inc.
Microbiology · 13d
Cleared May 20, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE
K861791 · JSK
Flow Laboratories, Inc.
Microbiology · 11d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
K861823 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
K861824 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 16, 1986
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
K860923 · GTZ
Self Care Systems, Inc.
Microbiology · 66d
Cleared May 16, 1986
MODIFIED UNISCEPT KB LABELING AMENDMENT
K861408 · JWY
Analytab Products, Inc.
Microbiology · 31d
Cleared May 16, 1986
REGAN-LOWE AGAR
K861734 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 10d
Cleared May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · LIN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 119d
Cleared May 13, 1986
THE CMV-IGM TEST
K860450 · LKQ
Microbiological Research Corp.
Microbiology · 98d