PHADEBAS ISOAMYLASE TEST— 510(k) K810584

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K810584 for PHADEBAS ISOAMYLASE TEST, Substantially Equivalent on 1981-05-13. Applicant: Pharmacia, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code CIW
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1981-03-04
Decision date: 1981-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)1981-08-03

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