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
3049–3072 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 14, 1983
IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
K832900 · GLZ
Bionetic Laboratory Products
Immunology · 77d
Cleared Nov 14, 1983
DEFAZOLIN 30MCG. SENSITIVITY DISCS
K832910 · JTN
Difco Laboratories, Inc.
Immunology · 77d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IMMUNOGLOBULINS-
K832256 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
K832258 · DEW
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN KAPPA AFFINITY
K832260 · DEO
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · CZN
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGA A CHAIN
K832263 · CZP
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGM H CHAIN
K832265 · DFT
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN KAPPA AFFINITY
K832266 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN LAMBA
K832267 · DES
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN LAMBA
K832270 · DEH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257 · CZN
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGM H CHAIN
K832259 · DFT
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN LAMBA AFFINITY
K832261 · DEH
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
FITC GOAT ANTI-HUMAN IGG Y CHAIN
K832264 · DEW
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 27, 1983
CMV IGM TEST
K831711 · LKQ
Gull Laboratories, Inc.
Immunology · 153d
Cleared Oct 14, 1983
FIAX IGG TEST
K832821 · DFI
Intl. Diagnostic Technology
Immunology · 56d
Cleared Oct 14, 1983
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896 · LHL
Biodan Medical Systems, Ltd.
Immunology · 52d
Cleared Oct 14, 1983
CEFUROXIME 30MCG. SENSITIVITY DISCS
K832909 · JTN
Difco Laboratories, Inc.
Immunology · 46d
Cleared Sep 29, 1983
DIACROM * ATIII
K832592 · JBQ
Wellcome Diagnostics
Immunology · 58d
Cleared Sep 29, 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726 · CDD
Diagnostic Products Corp.
Immunology · 48d
Cleared Sep 26, 1983
TOXO-SCREEN DA TEST
K831930 · LLA
Bd Becton Dickinson Vacutainer...
Immunology · 103d
Cleared Sep 26, 1983
TOXO IPA KIT IAN INDIRECT FLUORESCENT
K832069 · LJK
Bionetic Laboratory Products
Immunology · 91d
Cleared Sep 26, 1983
SELECTRO-DISC
K832436 · JTO
Lab Ability, Inc.
Immunology · 63d