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
3361–3384 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 26, 1980
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL
K792377 · DHX
Environmental Chemical Specialties
Immunology · 305d
Cleared Sep 26, 1980
CLINETICS PCA COLUMN
K801306 · DHX
Clinetics Corp.
Immunology · 115d
Cleared Sep 26, 1980
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
K801909 · DEX
J.T. Baker Chemical Co.
Immunology · 46d
Cleared Sep 16, 1980
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · DDB
J.T. Baker Chemical Co.
Immunology · 57d
Cleared Sep 16, 1980
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
K801662 · DEP
J.T. Baker Chemical Co.
Immunology · 57d
Cleared Sep 16, 1980
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
K801669 · DEM
J.T. Baker Chemical Co.
Immunology · 56d
Cleared Sep 16, 1980
NORDICLAB FERRITIN IRMA TEST
K801989 · DBF
Nordiclab Intl.
Immunology · 28d
Cleared Aug 20, 1980
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · DBF
Abbott Laboratories
Immunology · 29d
Cleared Aug 13, 1980
MRI HCG-BETA RIA KIT CAT. #MR-10100
K801491 · JHI
Microanalytic Research, Inc.
Immunology · 48d
Cleared Aug 13, 1980
VENTREX/SEP TSH TEST SET
K801560 · JLW
Ventrex Laboratories, Inc.
Immunology · 36d
Cleared Aug 13, 1980
FERRITIN RIA KIT
K801580 · DBF
Diagnostic Products Corp.
Immunology · 34d
Cleared Jul 14, 1980
DISC 120 TRANSPORTER
K801391 · JZW
Travenol Laboratories, S.A.
Immunology · 31d
Cleared Jul 08, 1980
HEMOPEXIN NEPHELOMETRIC ASSAY
K801432 · CZX
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jul 08, 1980
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433 · DAD
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jul 08, 1980
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
K801434 · DDG
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · DFT
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283 · CZP
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · DBI
J.T. Baker Chemical Co.
Immunology · 21d
Cleared Jun 30, 1980
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · CZW
J.T. Baker Chemical Co.
Immunology · 21d
Cleared Jun 20, 1980
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI
K801281 · DEW
J.T. Baker Chemical Co.
Immunology · 22d
Cleared May 28, 1980
AUTOFLUOR SYSTEM
K800698 · JZT
California Immuno Diagnostic, Inc.
Immunology · 61d
Cleared May 20, 1980
125I-IGE RADIOIMMUNOASSAY KIT
K801019 · DGC
Bio-Ria
Immunology · 20d
Cleared May 14, 1980
FERRITIRON KIT CAT. #RP-1100
K800710 · JQG
Ria Products, Inc.
Immunology · 44d
Cleared May 14, 1980
IMMUNOGLOBULIN E TEST KIT
K800995 · DGO
Calbiochem-Behring Corp.
Immunology · 19d