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
2473–2496 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · JMG
Baxter Healthcare Corp
Immunology · 36d
Cleared Apr 21, 1988
NOVA LITE(TM) ANA PLUS
K881339 · LLL
Inova Diagnostics, Inc.
Immunology · 23d