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
3841–3864 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 03, 1989
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · LIO
Diagnostic Products Corp.
Microbiology · 65d
Cleared Jul 25, 1989
LYME DISEASE MICROASSAY
K890843 · LSR
Diamedix Corp.
Microbiology · 154d
Cleared Jul 25, 1989
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · LKQ
Immuno Concepts, Inc.
Microbiology · 83d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Abbott Laboratories
Microbiology · 70d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
TOXO ELISA TEST SYSTEM
K891781 · LGD
Zeus Scientific, Inc.
Microbiology · 112d
Cleared Jul 14, 1989
BION EBV-M (VCA) TEST SYSTEM
K893240 · LJN
Bion Ent., Ltd.
Microbiology · 77d
Cleared Jul 14, 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · LKQ
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · LFX
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX TOXO IGG ANTIBODY ASSAY
K890031 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
IMX TOXO IGM ANTIBODY ASSAY
K890032 · LGD
Abbott Laboratories
Microbiology · 170d
Cleared Jun 23, 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · LFZ
Organon Teknika Corp.
Microbiology · 136d
Cleared Jun 23, 1989
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
K891393 · LFZ
Orgenics, Ltd.
Microbiology · 101d
Cleared Jun 23, 1989
CLEARVIEW STREP A
K893422 · GTZ
Unipath , Ltd.
Microbiology · 52d
Cleared Jun 23, 1989
CELLMATICS SHLAMYDIA DETECTION SYSTEM
K893669 · LKH
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Jun 21, 1989
MP TEST
K882596 · LJZ
Diatech Diagnostica , Ltd.
Microbiology · 362d
Cleared Jun 20, 1989
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639 · LJN
Diagnostic Technology, Inc.
Microbiology · 132d
Cleared Jun 20, 1989
HSV-CHECK(TM) TEST KIT
K890819 · HIS
Diagnostic Technology, Inc.
Microbiology · 123d
Cleared Jun 20, 1989
HSV-1 ELISA TEST SYSTEM
K891162 · GQL
Zeus Scientific, Inc.
Microbiology · 106d