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
1033–1056 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 22, 2000
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME...
K000879 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME...
K000880 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 18, 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · CDZ
Diagnostic Systems Laboratories, Inc.
Immunology · 44d
Cleared May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · JZO
Roche Diagnostics Corp.
Immunology · 119d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSA
K000749 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SCL-70
K000750 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSB
K000751 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- RNP
K000752 · LKO
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SM
K000755 · LKP
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
K994140 · MSW
Nichols Institute Diagnostics
Immunology · 153d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared Apr 27, 2000
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
K000701 · CFN
The Binding Site, Ltd.
Immunology · 57d
Cleared Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · JJX
Roche Diagnostics Corp.
Immunology · 29d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920 · MID
Corgenix, Inc.
Immunology · 35d
Cleared Apr 13, 2000
RANDOX PREALBUMIN
K000661 · JZJ
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Apr 13, 2000
BAYER PSA ASSAY
K994221 · LTJ
Bayer Corp.
Immunology · 120d
Cleared Apr 07, 2000
MDI SCL-70 TEST
K000934 · LJM
Micro Detect, Inc.
Immunology · 15d
Cleared Apr 05, 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489 · LLL
Helix Diagnostics, Inc.
Immunology · 51d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · DHR
Roche Diagnostics Corp.
Immunology · 48d
Cleared Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · JJX
Bio-Rad
Immunology · 230d
Cleared Apr 03, 2000
RANDOX FERRITIN
K000662 · DBF
Randox Laboratories, Ltd.
Immunology · 35d