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
1033–1056 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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