AMP ALKALINE PHOSPHATASE REAGENT KIT— 510(k) K931986

Name: FDA 510(k) clearance K931986
Creator: U.S. Food and Drug Administration
Published: 1993-09-08

Substantially Equivalent

Synermed, Inc.

FDA 510(k) clearance K931986 for AMP ALKALINE PHOSPHATASE REAGENT KIT, Substantially Equivalent on 1993-09-08. Applicant: Synermed, Inc.. Device class: 2.

Clearance details

Applicant: Synermed, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1993-04-22
Decision date: 1993-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Canada, CA

Download summary PDF View on FDA.gov ↗

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