HEMOTECT— 510(k) K822731

Substantially Equivalent

Bio-Chem Laboratories

FDA 510(k) clearance K822731 for HEMOTECT, Substantially Equivalent on 1982-10-18. Applicant: Bio-Chem Laboratories. Device class: 2.

Clearance details

Applicant: Bio-Chem Laboratories
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1982-09-13
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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