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
3889–3912 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared Apr 28, 1989
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670 · GNP
Electro-Nucleonics, Inc.
Microbiology · 253d
Cleared Apr 26, 1989
GLOVES, PATIENT EXAMINATION
K890344 · JTN
Tomarc (M) Sdn Bhd
Microbiology · 93d
Cleared Apr 21, 1989
FTK FECAL TRANSPORT KIT
K890134 · LIO
Evergreen Scientific, Inc.
Microbiology · 98d
Cleared Apr 18, 1989
MARDX LYME DISEASE IGG IFA TEST SYSTEM
K890053 · LSR
Mardx Diagnostics, Inc.
Microbiology · 102d
Cleared Apr 12, 1989
EBV EARLY ANTIGEN (R+D)
K884829 · JRY
Hillcrest Biologicals
Microbiology · 145d
Cleared Apr 12, 1989
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
K885344 · LGD
Orgenics, Ltd.
Microbiology · 105d
Cleared Apr 12, 1989
C. ALBICANS SCREEN
K891476 · JXC
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 27d
Cleared Apr 11, 1989
CMV-CUBE(TM)
K884842 · LFZ
Difco Laboratories, Inc.
Microbiology · 141d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD HERPES IGG TEST KIT
K884246 · LGC
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
K884247 · LFX
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · LFZ
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT
K884249 · LGD
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 04, 1989
GIARDEIA(TM)
K890774 · KHW
Antibodies, Inc.
Microbiology · 48d
Cleared Mar 27, 1989
CYTOMEGALOVIRUS IGG EIA KIT
K880433 · LFZ
De Ferris Laboratories, Inc.
Microbiology · 420d
Cleared Mar 27, 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399 · LFZ
United Biotech, Inc.
Microbiology · 228d
Cleared Mar 27, 1989
ANAEROBIC MIC PANEL
K884831 · JWY
Microtech Medical Systems, Inc.
Microbiology · 129d
Cleared Mar 27, 1989
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
K890840 · GTZ
Adi Diagnostics, Inc.
Microbiology · 34d
Cleared Mar 22, 1989
MICROTRAK CHLAMYDIA EIA
K890196 · LJC
Syva Co.
Microbiology · 63d
Cleared Mar 21, 1989
SAF FECAL COLLECTION KIT
K885244 · JSM
Precision Biologicals, Inc.
Microbiology · 89d