ACID PHOSPHOTASE REAGENT TEST AND KIT— 510(k) K902543

Name: FDA 510(k) clearance K902543
Creator: U.S. Food and Drug Administration
Published: 1990-09-07

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K902543 for ACID PHOSPHOTASE REAGENT TEST AND KIT, Substantially Equivalent on 1990-09-07. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code CKB
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1990-06-06
Decision date: 1990-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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