SINGLE VIAL LIPASE TEST KIT— 510(k) K802842

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K802842 for SINGLE VIAL LIPASE TEST KIT, Substantially Equivalent on 1980-12-18. Applicant: Biodynamics Corp.. Device class: 1.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1980-11-12
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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