GLYCOHEMOGLOBIN— 510(k) K810958

Substantially Equivalent

Macomb Chemical Co.

FDA 510(k) clearance K810958 for GLYCOHEMOGLOBIN, Substantially Equivalent on 1981-09-16. Applicant: Macomb Chemical Co.. Device class: 2.

Clearance details

Applicant: Macomb Chemical Co.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1981-04-08
Decision date: 1981-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Macomb Chemical Co.

K830095 — RAPID CHEM ANALYZER II1983-01-28
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Data sourced from openFDA. This site is unofficial and independent of the FDA.