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
1057–1080 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 27, 2000
RANDOX COMPLEMENT C4
K000468 · DBI
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C3
K000469 · CZW
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
K000286 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
K000287 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
VARELISA SM ANTIBODIES
K000312 · LKP
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO...
K000566 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · DHR
Cogent Diagnotics , Ltd.
Immunology · 135d
Cleared Mar 01, 2000
MDI DS-DNA TEST
K000477 · LRM
Micro Detect, Inc.
Immunology · 16d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · JIT
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · DBI
Dade Behring, Inc.
Immunology · 71d
Cleared Mar 01, 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · CZW
Dade Behring, Inc.
Immunology · 71d
Cleared Feb 23, 2000
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · JFH
Diagnostic Products Corp.
Immunology · 27d
Cleared Feb 18, 2000
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10,...
K000132 · DHB
Pharmacia & Upjohn Co.
Immunology · 31d
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · JZO
Zeus Scientific, Inc.
Immunology · 14d
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K000363 · DDC
Zeus Scientific, Inc.
Immunology · 14d
Cleared Feb 18, 2000
EU-TTG IGA ELISA
K994379 · MVM
Scimedx Corp.
Immunology · 53d
Cleared Feb 18, 2000
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · LRM
Diamedix Corp.
Immunology · 50d
Cleared Feb 04, 2000
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · DDG
Dade Behring, Inc.
Immunology · 45d
Cleared Feb 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · DHR
Cogent Diagnotics , Ltd.
Immunology · 42d
Cleared Feb 01, 2000
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · MID
Cogent Diagnotics , Ltd.
Immunology · 139d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993547 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K993549 · CFN
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148 · JQC
Implant Innovations, Inc.
Immunology · 55d
Cleared Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928 · DEW
Wako Chemicals USA, Inc.
Immunology · 61d