HDL PRECIPITATING REAGENT— 510(k) K893966

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K893966 for HDL PRECIPITATING REAGENT, Substantially Equivalent on 1989-07-25. Applicant: Diagnostic Systems. Device class: 1.

Clearance details

Applicant
Diagnostic Systems
Product code
Code LBR
Device class
Class 1
Regulation
21 CFR 862.1475
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gibbstown, NJ, US
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