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
2041–2064 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 02, 1992
REP IMMUNOFIX
K923658 · CFF
Helena Laboratories
Immunology · 102d
Cleared Nov 02, 1992
ACCUTEX IM RBC TEST
K924037 · KTN
J.S. Medical Assoc.
Immunology · 83d
Cleared Nov 02, 1992
KALESTAD ANA MICROPLATE EIA
K924087 · LJM
Bio-Rad Laboratories, Inc.
Immunology · 81d
Cleared Nov 02, 1992
ACCUTEX SLE LATEX TEST
K924248 · LJM
J.S. Medical Assoc.
Immunology · 70d
Cleared Oct 26, 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · MSJ
Instrumentation Laboratory CO
Immunology · 123d
Cleared Oct 26, 1992
IL TEST APOLIPOPROTEIN A1
K923087 · MSJ
Instrumentation Laboratory CO
Immunology · 123d
Cleared Oct 16, 1992
ENCORE SS-B
K922340 · LLL
Clark Laboratories, Inc.
Immunology · 150d
Cleared Oct 16, 1992
PULSE IM RED CELL TEST
K923767 · KTN
Pulse Scientific, Inc.
Immunology · 80d
Cleared Oct 13, 1992
ENCORE SS-A
K922157 · LLL
Clark Laboratories, Inc.
Immunology · 159d
Cleared Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · DHR
Bio-Rad
Immunology · 78d
Cleared Oct 05, 1992
TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
K922722 · DCK
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
K922725 · DHR
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
K922726 · KTN
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
PULSE RF TEST
K923771 · DHR
Pulse Scientific, Inc.
Immunology · 69d
Cleared Sep 29, 1992
QUANTA LITE(TM) IGA ACA
K922351 · MID
Inova Diagnostics, Inc.
Immunology · 133d
Cleared Sep 28, 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284 · DHB
Hycor Biomedical, Inc.
Immunology · 84d
Cleared Sep 28, 1992
QUANTA LITE ACA SCREEN
K923320 · MID
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Sep 25, 1992
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886 · MID
Shield Diagnostics, Ltd.
Immunology · 52d
Cleared Sep 25, 1992
ENCORE RHEUMATOID FACTOR EIA
K924056 · DHR
Clark Laboratories, Inc.
Immunology · 44d
Cleared Sep 23, 1992
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · JZG
Coulter Corp.
Immunology · 72d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · JNL
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Sep 22, 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · JNL
Cogent Diagnotics , Ltd.
Immunology · 75d
Cleared Sep 18, 1992
QUANTA LITE ENA ELISA
K922829 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-A ELISA
K922830 · LLL
Inova Diagnostics, Inc.
Immunology · 98d