PROTEIN-BOUND GLUCOSE ASSAYN KIT— 510(k) K930823

Name: FDA 510(k) clearance K930823
Creator: U.S. Food and Drug Administration
Published: 1993-08-19

Substantially Equivalent

Diagnostic Specialties

FDA 510(k) clearance K930823 for PROTEIN-BOUND GLUCOSE ASSAYN KIT, Substantially Equivalent on 1993-08-19. Applicant: Diagnostic Specialties. Device class: 2.

Clearance details

Applicant: Diagnostic Specialties
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1993-02-17
Decision date: 1993-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Metuchen, NJ, US

Download summary PDF View on FDA.gov ↗

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