CRITIC C LEVEL I & II— 510(k) K853943

Substantially Equivalent

Dimension Diagnostics

FDA 510(k) clearance K853943 for CRITIC C LEVEL I & II, Substantially Equivalent on 1985-12-23. Applicant: Dimension Diagnostics.

Clearance details

Applicant: Dimension Diagnostics
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1985-09-24
Decision date: 1985-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Peters, MO, US

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