TGL REAGENT— 510(k) K852010

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K852010 for TGL REAGENT, Substantially Equivalent on 1985-05-30. Applicant: Alpkem Corp.. Device class: 1.

Clearance details

Applicant: Alpkem Corp.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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