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
2473–2496 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 14, 1988
HOUSE DUST
K875110 · DHB
Incstar Corp.
Immunology · 183d
Cleared Jun 14, 1988
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · MSJ
Atlantic Antibodies
Immunology · 47d
Cleared Jun 10, 1988
IMMUNOGLOBULIN A TEST SYSTEM
K881827 · CFQ
The Binding Site, Ltd.
Immunology · 42d
Cleared Jun 10, 1988
PHARMACIA IGE RIACT
K881892 · DGC
Pharmacia, Inc.
Immunology · 37d
Cleared Jun 08, 1988
RID PLATE READER
K881174 · JZQ
The Binding Site, Ltd.
Immunology · 82d
Cleared Jun 08, 1988
NOVA LITE(TM) AUTOANTIBODY CONTROLS
K881340 · LLL
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
K880784 · DEW
Wako Chemicals USA, Inc.
Immunology · 101d
Cleared Jun 06, 1988
IMMUNOGLOBULIN M TEST SYSTEM
K881828 · CFQ
The Binding Site, Ltd.
Immunology · 38d
Cleared Jun 06, 1988
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K881933 · JZO
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 27d
Cleared May 16, 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · DHB
Pharmacia, Inc.
Immunology · 75d
Cleared May 16, 1988
WESBLOT RNP-SM TEST
K881379 · LKP
American Bionetics, Inc.
Immunology · 45d
Cleared May 11, 1988
MARSH ELDER ALLERGEN DISC
K874540 · DHB
Incstar Corp.
Immunology · 190d
Cleared May 11, 1988
WALNUT ALLERGEN DISC
K874883 · DHB
Incstar Corp.
Immunology · 162d
Cleared May 11, 1988
INCSTAR'S BIRCH ALLERGEN DISC
K880168 · DHB
Incstar Corp.
Immunology · 117d
Cleared May 11, 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · DHB
Incstar Corp.
Immunology · 112d
Cleared May 11, 1988
IMX FERRITIN
K881345 · DGD
Abbott Laboratories
Immunology · 42d
Cleared Apr 21, 1988
GOLDENROD ALLERGEN DISC
K875163 · DHB
Incstar Corp.
Immunology · 127d
Cleared Apr 21, 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244 · DHB
Diagnostic Products Corp.
Immunology · 121d
Cleared Apr 21, 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · DHB
Diagnostic Products Corp.
Immunology · 99d
Cleared Apr 21, 1988
INCSTAR'S DANDELION ALLERGEN DISC
K880187 · DHB
Incstar Corp.
Immunology · 97d
Cleared Apr 21, 1988
MESQUITE ALLERGEN DISC
K880415 · DHB
Incstar Corp.
Immunology · 80d
Cleared Apr 21, 1988
WHITE ASH ALLERGEN DISC
K880567 · DHB
Incstar Corp.
Immunology · 71d
Cleared Apr 21, 1988
NOVA GEL (TM) SCL-70
K880897 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 21, 1988
QM300 CALIBRATOR D PACK
K881127 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d