CRE BUFFER CRE DYE— 510(k) K851993

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K851993 for CRE BUFFER CRE DYE, Substantially Equivalent on 1985-05-30. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant: Alpkem Corp.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

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