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
3817–3840 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 15, 1989
CAPTIA(R) RUBELLA-M
K885300 · LFX
Mercia Diagnostics , Ltd.
Microbiology · 231d
Cleared Aug 15, 1989
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
K892206 · LSR
Mardx Diagnostics, Inc.
Microbiology · 134d
Cleared Aug 15, 1989
IFA SENSIBAC GENTAMYCIN
K892720 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
IFA SENSIBAC PENICILLIN
K892726 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
K893519 · KZB
Statlabs, Inc.
Microbiology · 99d
Cleared Aug 15, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · JWY
Baxter Healthcare Corp
Microbiology · 74d
Cleared Aug 15, 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 64d
Cleared Aug 15, 1989
MERIVIEW TM TRICHOMONAS
K894246 · JWZ
Meridian Diagnostics, Inc.
Microbiology · 55d
Cleared Aug 15, 1989
CHLAMYDIA (LGV-1)
K894625 · LKI
Bion Ent., Ltd.
Microbiology · 26d
Cleared Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002 · LIN
Baxter Healthcare Corp
Microbiology · 66d
Cleared Aug 03, 1989
RUBELLA ELISA TEST SYSTEM
K891783 · LFX
Zeus Scientific, Inc.
Microbiology · 132d
Cleared Aug 03, 1989
IFA SENSIBAC NEOMYCIN
K892714 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC NITROFURANTOIN
K892715 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC BACITRACIN
K892717 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC TETRACYCLINE
K892718 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC ERYTHROMYCIN
K892719 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC CINOXACIN
K892722 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC POLYMYXIN B
K892723 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC STREPTOMYCIN
K892724 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC VANCOMYCIN
K892725 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC INIPENEM
K892727 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC TOBRAMYCIN
K892729 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC CHLROAMPHENICOL
K892730 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
K893419 · DEW
Coulter Immunology
Microbiology · 93d