ABSORBANCE (ABS) TEST PAK— 510(k) K854784

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K854784 for ABSORBANCE (ABS) TEST PAK, Substantially Equivalent on 1985-12-19. Applicant: Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Diagnostic Systems
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1985-11-29
Decision date: 1985-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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