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
1249–1272 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
K981912 · CFN
The Binding Site, Ltd.
Immunology · 186d
Cleared Nov 30, 1998
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
K982898 · MOB
Immco Diagnostics, Inc.
Immunology · 105d