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
1249–1272 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · LOJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 109d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DDG
DiaSorin, Inc.
Immunology · 46d
Cleared Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924 · DHN
Immuno Concepts, Inc.
Immunology · 44d
Cleared Dec 18, 1998
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · LRM
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
K984397 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 17, 1998
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954 · DHB
Diagnostic Products Corp.
Immunology · 42d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
K984175 · MID
Zeus Scientific, Inc.
Immunology · 27d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME...
K984315 · MOB
Zeus Scientific, Inc.
Immunology · 14d
Cleared Dec 17, 1998
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
K984325 · JJY
Bio-Rad
Immunology · 14d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST...
K984347 · MID
Zeus Scientific, Inc.
Immunology · 13d
Cleared Dec 16, 1998
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
K983807 · JJY
Bio-Rad
Immunology · 49d
Cleared Dec 14, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY...
K983340 · DBF
Beckman Coulter, Inc.
Immunology · 82d
Cleared Dec 14, 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · DDR
Dade Behring, Inc.
Immunology · 28d
Cleared Dec 10, 1998
CLEARVIEW IM
K981946 · KTN
Unipath , Ltd.
Immunology · 190d
Cleared Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · DDR
Dade Behring, Inc.
Immunology · 17d
Cleared Dec 08, 1998
BTA STAT TEST PRESCRIPTION HOME USE
K974845 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 355d
Cleared Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · MSV
Corgenix, Inc.
Immunology · 151d
Cleared Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · MSV
Corgenix, Inc.
Immunology · 146d
Cleared Dec 07, 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · LOJ
Diagnostic Products Corp.
Immunology · 81d
Cleared Dec 07, 1998
ANTI-TG IGG ELISA TEST SYSTEM
K983553 · JZO
Columbia Bioscience, Inc.
Immunology · 59d
Cleared Dec 07, 1998
ABBOTT ARCHITECT FERRITIN
K983759 · DBF
Abbott Laboratories
Immunology · 42d