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
4177–4200 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 12, 1988
LEPTOSPIROSIS IHA
K880417 · GRY
Hillcrest Biologicals
Microbiology · 71d
Cleared Apr 12, 1988
GRAM NEGATIVE MIC/COMBO PANELS
K880430 · JWY
Baxter Healthcare Corp
Microbiology · 71d
Cleared Apr 12, 1988
V-TREND STREP A TEST
K880483 · GTZ
Texas Immunology, Inc.
Microbiology · 67d
Cleared Apr 12, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
K880824 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 42d
Cleared Apr 12, 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
ASO SLIDE TEST
K881209 · GTQ
Ncs Diagnostics, Inc.
Microbiology · 22d
Cleared Apr 04, 1988
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
K881243 · LFX
Labsystems, Inc.
Microbiology · 14d
Cleared Apr 01, 1988
NUTRIENT GELATIN - PRODUCT NUMBER T2860
K880946 · JSF
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Apr 01, 1988
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE
K880947 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Apr 01, 1988
PYR/ESCULIN DISK
K880950 · JTO
Remel Co.
Microbiology · 25d
Cleared Mar 31, 1988
VZV TEST
K875358 · GQX
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Mar 31, 1988
MRVP BROTH
K880116 · JSE
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, ONITHINE
K880119 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, LYSINE
K880120 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, BASE
K880121 · JSH
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIDDLEBROOK 7H9 BROTH
K880122 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN SLANT
K880123 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, W/NACL
K880124 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, SELECTIVE
K880125 · JSI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LAURYL TRYPTOSE BROTH
K880126 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, GRUFT
K880131 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIL MEDIUM
K880133 · JSE
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIDDLEBROOK 7H11 AGAR
K880134 · KZI
Hardy Media
Microbiology · 85d