SANDARE ALKALINE PHOSPHATASE PROCEDURE— 510(k) K844498

Name: FDA 510(k) clearance K844498
Creator: U.S. Food and Drug Administration
Published: 1984-12-10

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K844498 for SANDARE ALKALINE PHOSPHATASE PROCEDURE, Substantially Equivalent on 1984-12-10. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code CIO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1984-11-20
Decision date: 1984-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Desoto, TX, US

Download summary PDF View on FDA.gov ↗

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