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
2041–2064 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 25, 1992
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
K923832 · DGC
Kabi Pharmacia, Inc.
Immunology · 120d
Cleared Nov 06, 1992
MYOGLOBIN ELISA TEST KIT
K923195 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 129d
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