SANDARE IRON PROCEDURE— 510(k) K851394

Name: FDA 510(k) clearance K851394
Creator: U.S. Food and Drug Administration
Published: 1985-04-30

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K851394 for SANDARE IRON PROCEDURE, Substantially Equivalent on 1985-04-30. Applicant: Sandare Chemical Co., Inc.. Device class: 1.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1985-04-09
Decision date: 1985-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Desoto, TX, US

Download summary PDF View on FDA.gov ↗

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