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
3121–3144 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177 · KXT
American Dade
Immunology · 36d
Cleared May 16, 1983
CORDIA PAP
K831105 · JFH
Cordis Corp.
Immunology · 41d
Cleared May 16, 1983
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
K831154 · LES
American Dade
Immunology · 38d
Cleared May 05, 1983
BTC URINE LCG ASSAY
K831125 · JHJ
Btc Diagnostics, Inc.
Immunology · 30d
Cleared May 04, 1983
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT
K831100 · DBM
Medical Diagnostics, Ca.
Immunology · 29d
Cleared Apr 27, 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817 · DGC
Ventrex Laboratories, Inc.
Immunology · 43d
Cleared Apr 27, 1983
NETILMICIN 30MCG. SENSITIVITY DISCS
K830956 · JTN
Difco Laboratories, Inc.
Immunology · 33d
Cleared Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · LLL
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Apr 27, 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045 · DHB
Pharmacia, Inc.
Immunology · 27d
Cleared Apr 27, 1983
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
K831054 · DHN
Immuno-Products Industries
Immunology · 26d
Cleared Apr 27, 1983
NEW ALLERGEN DISC -VAST VENTEX ALLERGY
K831091 · DHB
Ventrex Laboratories, Inc.
Immunology · 23d
Cleared Apr 27, 1983
TIA-IGG REAGENT & CALIBRATOR SETS
K831101 · DEW
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 27, 1983
TIA-IGA REAGENT & CALIBRATOR SETS
K831102 · CZP
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 27, 1983
TIA-IGM REAGENT & CALIBRATOR SETS
K831103 · DFT
Worthington Diagnostic Systems
Immunology · 22d
Cleared Apr 18, 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · DHR
Emd Chemicals, Inc.
Immunology · 33d
Cleared Apr 18, 1983
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
K830934 · CJW
Quantimetrix Corp.
Immunology · 26d
Cleared Apr 08, 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSORB
K830653 · DGO
Diagnostic Reagent Tech.
Immunology · 38d
Cleared Apr 08, 1983
FIAX COMPLEMENT C4 TEST KIT
K830669 · DBI
Intl. Diagnostic Technology
Immunology · 35d
Cleared Apr 05, 1983
FIAX COMPLEMENT C3 TEST KIT
K830668 · CZW
Intl. Diagnostic Technology
Immunology · 32d
Cleared Mar 31, 1983
COMBION SKIN TEST
K830688 · LKH
Nicholas H. Maganias
Immunology · 27d
Cleared Mar 25, 1983
PHADEZYM B2 MICRO TEST 100
K830280
Pharmacia, Inc.
Immunology · 58d
Cleared Mar 24, 1983
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592 · DHB
Pharmacia, Inc.
Immunology · 108d
Cleared Mar 24, 1983
TITAN IMMUNO-FIX
K830594 · DEW
Helena Laboratories
Immunology · 28d
Cleared Mar 24, 1983
RA SCREENING TEST
K830611 · DHR
Tago, Inc.
Immunology · 24d