ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT— 510(k) K880177

Name: FDA 510(k) clearance K880177
Creator: U.S. Food and Drug Administration
Published: 1988-04-05

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K880177 for ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT, Substantially Equivalent on 1988-04-05. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code CIO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1988-01-15
Decision date: 1988-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Park, MI, US

Download summary PDF View on FDA.gov ↗

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