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
1849–1872 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 02, 1994
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
K944486 · JJY
International Enzymes, Inc.
Immunology · 80d
Cleared Dec 02, 1994
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
K944513 · JJY
International Enzymes, Inc.
Immunology · 78d
Cleared Nov 21, 1994
DAKO MOUSE ANTI-HUMAN T-CELL
K924804 · DEH
Dako Corp.
Immunology · 788d
Cleared Nov 21, 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · LLL
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
K943076 · LLL
Inova Diagnostics, Inc.
Immunology · 119d
Cleared Oct 20, 1994
N LATEX RF
K942328 · DHR
Behring Diagnostics, Inc.
Immunology · 168d
Cleared Oct 13, 1994
APHLELISA KIT
K933588 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 444d
Cleared Oct 03, 1994
BEHRING NEPHELOMETER II
K943997 · DEW
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Oct 03, 1994
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · DCK
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Oct 03, 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · DCK
Behring Diagnostics, Inc.
Immunology · 26d
Cleared Sep 26, 1994
ANTI-RETICULIN ANTIBODY (ARA) TEST
K913360 · DBL
Immco Diagnostics, Inc.
Immunology · 1155d
Cleared Sep 26, 1994
IGM RHEUMATOID FACTOR
K942272 · DHR
Immco Diagnostics, Inc.
Immunology · 139d
Cleared Sep 20, 1994
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · MID
Elias U.S.A., Inc.
Immunology · 236d
Cleared Sep 09, 1994
PLASMINOGEN RID TEST KIT
K941346 · DDX
The Binding Site, Ltd.
Immunology · 172d
Cleared Sep 09, 1994
TNT TROPONIN T
K942632 · JJX
Streck Laboratories, Inc.
Immunology · 98d
Cleared Sep 07, 1994
VENTANA EMA PRIMARY ANDIBODY
K940243 · DHF
Ventana Medical Systems, Inc.
Immunology · 231d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES ELISA COMBI KIT
K943098 · DAS
Research Diagnostics, Inc.
Immunology · 71d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
K943205 · DAS
Research Diagnostics, Inc.
Immunology · 64d
Cleared Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · CGN
Beckman Coulter, Inc.
Immunology · 57d
Cleared Jul 28, 1994
ANA SCREEN ELISA TEST SYSTEM
K940362 · LLL
Zeus Scientific, Inc.
Immunology · 183d
Cleared Jul 18, 1994
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
K936010 · DDC
Biomerica, Inc.
Immunology · 214d
Cleared Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · LJM
Bio-Rad
Immunology · 93d
Cleared Jun 30, 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · MID
Hemagen Diagnostics, Inc.
Immunology · 78d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847 · DBF
Abbott Laboratories
Immunology · 195d