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
1057–1080 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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