SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS— 510(k) K800780

Name: FDA 510(k) clearance K800780
Creator: U.S. Food and Drug Administration
Published: 1980-04-24

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K800780 for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS, Substantially Equivalent on 1980-04-24. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-04-08
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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