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
2761–2784 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 15, 1986
SHORT RAGWEED ALLERGEN DISC
K854756 · DHB
Immuno Nuclear Corp.
Immunology · 169d
Cleared May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · LLL
Immuno Concepts, Inc.
Immunology · 100d
Cleared May 13, 1986
MONOSTAR SYSTEM: IM LATEX TEST
K861452 · KTN
U.S. Health Resources Corp.
Immunology · 25d
Cleared Apr 25, 1986
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K861167 · CZP
Atlantic Antibodies
Immunology · 28d
Cleared Apr 25, 1986
QUIDEL ALLERGY SCREEN
K861171 · DGC
Quidel Corp.
Immunology · 28d
Cleared Apr 25, 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184 · DHB
Pharmacia, Inc.
Immunology · 25d
Cleared Apr 25, 1986
IAP PLATE TEST
K861336 · LKL
Scientific Sales Intl., Inc.
Immunology · 16d
Cleared Apr 22, 1986
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865 · DHB
Pharmacia, Inc.
Immunology · 144d
Cleared Apr 22, 1986
THABEST-IGE
K855053 · DHB
Visual Diagnostics, Inc.
Immunology · 126d
Cleared Apr 22, 1986
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · DHR
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Apr 22, 1986
FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
K860027 · DHB
Alerchek, Inc.
Immunology · 109d
Cleared Apr 18, 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · KTN
Gamma Biologicals, Inc.
Immunology · 31d
Cleared Apr 15, 1986
BEHRING NEPHELOMETER SYSTEM
K860894 · CFN
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Apr 11, 1986
TOTAL IGE-IRMA RIA KIT
K860032 · DGC
Diagnostic Products Corp.
Immunology · 95d
Cleared Apr 11, 1986
ECHOCLONAL HTSH IRMA
K860288 · JLW
Bio-Rad
Immunology · 73d
Cleared Apr 07, 1986
EIA MONOCLONAL TOTAL IGE KIT
K860033 · DGC
Diagnostic Products Corp.
Immunology · 91d
Cleared Mar 28, 1986
ENZYMUN-TEST FERRITIN
K860137 · DBF
Boehringer Mannheim Corp.
Immunology · 73d
Cleared Mar 28, 1986
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · DDB
Sigma Diagnostics, Inc.
Immunology · 73d
Cleared Mar 28, 1986
BIOGRAM APO A1/B
K860629 · MSJ
Bio-Rad
Immunology · 37d
Cleared Mar 28, 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · LLL
Immuno Concepts, Inc.
Immunology · 36d
Cleared Mar 28, 1986
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · DGO
Nichols Institute Diagnostics
Immunology · 21d
Cleared Mar 14, 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · JIX
Kallestad Laboratories, Inc.
Immunology · 88d
Cleared Feb 28, 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · DFT
Kallestad Laboratories, Inc.
Immunology · 74d
Cleared Feb 26, 1986
CPR SLIDE EIKEN
K854819 · DCN
Syn-Kit, Inc.
Immunology · 85d