HEPCOL SYSTEM B-10 & B-10-P— 510(k) K830665

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K830665 for HEPCOL SYSTEM B-10 & B-10-P, Substantially Equivalent on 1983-06-08. Applicant: Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Hemotec, Inc.
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 1983-03-03
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.