SANDARE CYANMETHEMOGLOBIN STANDARD— 510(k) K792358

Name: FDA 510(k) clearance K792358
Creator: U.S. Food and Drug Administration
Published: 1979-12-31

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K792358 for SANDARE CYANMETHEMOGLOBIN STANDARD, Substantially Equivalent on 1979-12-31. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1979-11-21
Decision date: 1979-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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