BARBITURATE ENZYME IMMUNOASSAY KIT— 510(k) K882663

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K882663 for BARBITURATE ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1988-09-19. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant
General Diagnostics
Product code
Code DIS
Device class
Class 2
Regulation
21 CFR 862.3150
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck, NY, US
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