SANDARE GLYCOHEMOGLOBIN PROCEDURE— 510(k) K862556

Name: FDA 510(k) clearance K862556
Creator: U.S. Food and Drug Administration
Published: 1986-08-08

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K862556 for SANDARE GLYCOHEMOGLOBIN PROCEDURE, Substantially Equivalent on 1986-08-08. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1986-07-03
Decision date: 1986-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Desoto, TX, US

Download summary PDF View on FDA.gov ↗

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