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
1009–1032 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Theratest Laboratories, Inc.
Immunology · 26d
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