Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1153–1176 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 24, 1999
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942 · MLE
Cogent Diagnotics , Ltd.
Immunology · 76d
Cleared Aug 09, 1999
TOUCH TEAR IGE MICROASSAY KIT
K991316 · DGC
Touch Scientific, Inc.
Immunology · 112d
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