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
1009–1032 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 11, 2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · LRM
Helix Diagnostics, Inc.
Immunology · 81d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · DHR
Roche Diagnostics Corp.
Immunology · 14d
Cleared Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
K001127 · MOB
The Binding Site, Ltd.
Immunology · 149d
Cleared Aug 30, 2000
TOTAL PSA MICROTITER ELISA
K002121 · LTJ
Oncogene Science, Inc.
Immunology · 48d
Cleared Aug 30, 2000
COMPLEXED PSA MICROTITER ELISA
K002313 · LTJ
Oncogene Science, Inc.
Immunology · 30d
Cleared Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · DCK
The Binding Site, Ltd.
Immunology · 86d
Cleared Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556 · DHN
The Binding Site, Ltd.
Immunology · 95d
Cleared Aug 21, 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981 · MID
Axis-Shield , Ltd.
Immunology · 53d
Not Cleared Aug 16, 2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
DEN000007 · NBT
Inova Diagnostics, Inc.
Immunology · 29d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · JIS
Roche Diagnostics Corp.
Immunology · 8d
Cleared Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
K001009 · DCK
Randox Laboratories, Ltd.
Immunology · 128d
Cleared Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...
K002107 · MVM
Scimedx Corp.
Immunology · 23d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
K001931 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
K001933 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
K001934 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
K001919 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
K001920 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
K001921 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jun 28, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
K994419 · LTJ
Qualisys Diagnostics, Inc.
Immunology · 182d
Cleared Jun 09, 2000
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
K000336 · NBO
Rhigene, Inc.
Immunology · 127d
Cleared Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574 · MID
Axis-Shield
Immunology · 18d
Cleared Jun 07, 2000
QUANTA LITE LKM-1 ELISA
K000535 · NBS
Inova Diagnostics, Inc.
Immunology · 111d
Cleared Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN...
K001393 · MST
Zeus Scientific, Inc.
Immunology · 35d
Cleared Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · JJX
Roche Diagnostics Corp.
Immunology · 64d