HEMACAL— 510(k) K831306

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K831306 for HEMACAL, Substantially Equivalent on 1983-06-16. Applicant: Hematology Marketing Assoc.. Device class: 2.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1983-04-22
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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