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
3169–3192 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 09, 1983
LEVINE EMB AGAR
K830073 · JSH
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
CHOCOLATE AGAR, ENRICHED
K830074 · KZI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
COLUMBIA SHEEP BLOOD AGAR 5%
K830075 · JSG
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
CAMPYLOCACTER SELECTIVE AGAR BLASER'S
K830076 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
BRAIN HEART INFUSION AGAR
K830077 · JSG
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
BLOOD AGAR(TSA W/5% SHEEP BLOOD)
K830078 · KZI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
BISMUTH SULFITE AGAR
K830079 · JSI
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
BILE ESCULIN AGAR
K830081 · JSJ
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
Q-CHECK CULTI-LOOPS
K830133 · JTR
Lab Ability, Inc.
Immunology · 27d
Cleared Jan 14, 1983
TOTAL IGE-FAST TEST
K823494 · DGC
Axonics, Inc.
Immunology · 52d
Cleared Jan 12, 1983
PHADEBAS RAST ALLERGEN DISCS
K823841 · DGC
Pharmacia, Inc.
Immunology · 22d
Cleared Jan 12, 1983
PHADEZYM RAST ALLERGEN DISCS
K823842 · DGC
Pharmacia, Inc.
Immunology · 22d
Cleared Jan 09, 1983
Q-CHECK REAGENT STANDARDS
K830134 · LJG
Lab Ability, Inc.
Immunology
Cleared Dec 30, 1982
PHADEBACT CSF TEST 20
K822810 · GTJ
Pharmacia, Inc.
Immunology · 101d
Cleared Dec 30, 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567 · CZP
Syva Co.
Immunology · 27d
Cleared Dec 30, 1982
ANTI SERA TO HUMAN OROSCOMUCOID
K823765 · DEX
Kent Laboratories, Inc.
Immunology · 16d
Cleared Dec 28, 1982
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · JJX
Hoffmann-La Roche, Inc.
Immunology · 155d
Cleared Dec 28, 1982
H. INFLUENZA B ANTISERA FOR CIE
K823348 · GRP
Diagnostica, Inc.
Immunology · 49d
Cleared Dec 15, 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · DGC
Kallestad Laboratories, Inc.
Immunology · 30d
Cleared Dec 15, 1982
ALLERCOAT ALLERGEN DISCS
K823470 · DHB
Kallestad Laboratories, Inc.
Immunology · 23d
Cleared Dec 14, 1982
CARCINO-CEK
K823353 · JJX
Biologics Intl., Inc.
Immunology · 35d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · DCK
Syva Co.
Immunology · 24d
Cleared Nov 16, 1982
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · DDB
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Nov 10, 1982
ALLERGENETICS IGE-FAST TEST
K822341 · DGC
Allergenetics
Immunology · 98d