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
4705–4728 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · GQG
Kallestad Laboratories, Inc.
Microbiology · 70d
Cleared Sep 19, 1986
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
K863519 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR
K863523 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
REGAN-LOWE CHARCOAL AGAR
K863524 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
K863525 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
YEP (YEAST EXTRACT PHOSPHATE) AGAR
K863526 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 17, 1986
RESISTANT 6 MIC PANEL
K862978 · JWY
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · LLH
Marion Laboratories, Inc.
Microbiology · 8d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429 · GQG
Abbott Laboratories
Microbiology · 82d
Cleared Sep 16, 1986
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · GTY
Orion Diagnostica, Inc.
Microbiology · 78d
Cleared Sep 16, 1986
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K862914 · JTR
Trend Scientific, Inc.
Microbiology · 46d
Cleared Sep 16, 1986
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K863099 · JJK
Abbott Laboratories
Microbiology · 34d
Cleared Sep 16, 1986
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
K863423 · JTC
Plastic Injectors, Inc.
Microbiology · 12d
Cleared Sep 15, 1986
SERO-STAT R II STAPHYLOCOCCUS TEST
K863025 · LHT
Scott Laboratories, Inc.
Microbiology · 35d
Cleared Sep 15, 1986
BACTEC 13A MEDIUM (7H13)
K863191 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Sep 15, 1986
NEIS NZY
K863216 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 26d
Cleared Sep 11, 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · LGD
Organon Teknika Corp.
Microbiology · 94d
Cleared Sep 11, 1986
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · LQM
American Micro Scan
Microbiology · 62d
Cleared Sep 11, 1986
CODE-A-WELL SERIES 1-600, 1-625
K863374 · JTC
Plastic Injectors, Inc.
Microbiology · 8d
Cleared Sep 08, 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · LGD
Organon Teknika Corp.
Microbiology · 91d
Cleared Sep 03, 1986
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 55d
Cleared Sep 03, 1986
CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
K863289 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Aug 27, 1986
ANAEROBE RAPID CHROMOGENIC ID PANEL
K862332 · JSP
American Micro Scan
Microbiology · 69d