ABSORBANCE TEST SOLUTION— 510(k) K853533

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K853533 for ABSORBANCE TEST SOLUTION, Substantially Equivalent on 1985-09-16. 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: 1985-08-23
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.