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
3769–3792 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 31, 1989
OLYMPUS PK-TP SYSTEM REACTIVE CONTROL
K894617 · GMI
Schiff & Co.
Microbiology · 103d
Cleared Oct 30, 1989
IMMUNODOT LYME TEST
K894410 · LSR
General Biometrics, Inc.
Microbiology · 105d
Cleared Oct 30, 1989
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 76d
Cleared Oct 30, 1989
FASTEC 901 AGGLUTINATION PATTERN READER
K895967 · JJQ
Schiff & Co.
Microbiology · 18d
Cleared Oct 24, 1989
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
K894486 · GTQ
Biokit USA, Inc.
Microbiology · 98d
Cleared Oct 24, 1989
VARICELLA ZOSTER VIRUS
K894622 · GQW
Bion Ent., Ltd.
Microbiology · 96d
Cleared Oct 24, 1989
FDL, INC.'S TRANSPORT SYSTEM
K895187 · JTW
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 74d
Cleared Oct 24, 1989
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · JTN
Organon Teknika Corp.
Microbiology · 49d
Cleared Oct 16, 1989
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
K893753 · LHK
Bd Becton Dickinson Vacutainer...
Microbiology · 150d
Cleared Oct 16, 1989
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
K894261 · GMN
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
RUBELLA ANTIGEN AND CONTROL ANTIGEN
K894262 · GON
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
IMMUNODOT RUBELLA TEST
K894546 · LFX
General Biometrics, Inc.
Microbiology · 87d
Cleared Oct 16, 1989
RESPIRATORY SYNCYTIAL VIRUS
K894623 · LKT
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
MUMPS VIRUS
K894624 · GRA
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
K894626 · LLM
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
IMMUNO/ASO
K894780 · GTQ
Immunostics Co., Inc.
Microbiology · 81d
Cleared Oct 16, 1989
FIAX EB VCA-M TEST KIT
K894932 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 74d
Cleared Oct 10, 1989
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 116d
Cleared Sep 28, 1989
ROSCO PYRR
K894221 · JTO
Pro-Lab, Inc.
Microbiology · 101d
Cleared Sep 26, 1989
RAPIDEC UR
K894805 · JXA
Dms Products, Inc.
Microbiology · 60d
Cleared Sep 21, 1989
IFA SENSIBAC NORFLOXACIN
K892728 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 160d
Cleared Sep 19, 1989
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
K894609 · LSR
Mardx, Inc.
Microbiology · 61d
Cleared Sep 15, 1989
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · JXA
Gen-Probe, Inc.
Microbiology · 165d
Cleared Sep 13, 1989
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
K892202 · LFX
Gull Laboratories, Inc.
Microbiology · 163d