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: Immunology ×
3,792 results
1153–1176 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 09, 1999
KRONUS OPTIQUANT THYROGLOBULIN KIT
K991720 · MSW
Unchanged
Immunology · 81d
Cleared Aug 09, 1999
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · MVJ
Cogent Diagnotics , Ltd.
Immunology · 67d
Cleared Aug 05, 1999
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K992157 · DBF
Chiron Diagnostics Corp.
Immunology · 41d
Cleared Aug 02, 1999
N LATEX STFR REAGENT
K991157 · DDG
Dade Behring, Inc.
Immunology · 117d
Cleared Jul 28, 1999
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
K991945 · DGC
Pharmacia & Upjohn Co.
Immunology · 49d
Cleared Jul 23, 1999
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K992041 · LJM
Immuno Concepts, Inc.
Immunology · 36d
Cleared Jul 08, 1999
QUALISYS PSA IMMUNOASSAY
K990234 · LTJ
Qualisys Diagnostics, Inc.
Immunology · 164d
Cleared Jul 07, 1999
N LATEX IGE MONO REAGENT
K991787 · DGC
Dade Behring, Inc.
Immunology · 43d
Cleared Jun 30, 1999
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · CGN
Chiron Diagnostics Corp.
Immunology · 54d
Cleared Jun 28, 1999
POLYSLIT IFE KIT
K990998 · CFF
Helena Laboratories
Immunology · 95d
Cleared Jun 25, 1999
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
K991610 · DDC
Zeus Scientific, Inc.
Immunology · 46d
Cleared Jun 21, 1999
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · LOJ
Diagnostic Systems Laboratories, Inc.
Immunology · 153d
Cleared Jun 17, 1999
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179 · DDC
Zeus Scientific, Inc.
Immunology · 71d
Cleared Jun 17, 1999
QUANTA LITE ANA ELISA
K991657 · LLL
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Jun 10, 1999
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
K991467 · DHR
Kamiya Biomedical Co.
Immunology · 44d
Cleared Jun 09, 1999
K-ASSAY RHEUMATOID FACTOR
K991409 · DHR
Kamiya Biomedical Co.
Immunology · 48d
Cleared Jun 03, 1999
AIA-PACK CA 125
K990431 · LTK
Tosoh Medics, Inc.
Immunology · 112d
Cleared Jun 01, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K990943 · DHX
Ortho-Clinical Diagnostics, Inc.
Immunology · 71d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d
Cleared Jun 01, 1999
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY...
K991707 · DHX
Beckman
Immunology · 13d
Cleared May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
K990016 · JJY
Ortho-Clinical Diagnostics, Inc.
Immunology · 135d
Cleared May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO...
K983715 · LTK
Bayer Corp.
Immunology · 205d
Cleared May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS...
K983875 · LTK
Ortho-Clinical Diagnostics, Inc.
Immunology · 193d
Cleared May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210,...
K991048 · DHB
Pharmacia & Upjohn Co.
Immunology · 45d