HEMOTEC ACT I SYSTEM— 510(k) K843459

Substantially Equivalent

Hemotec, Inc.

FDA 510(k) clearance K843459 for HEMOTEC ACT I SYSTEM, Substantially Equivalent on 1984-12-12. Applicant: Hemotec, Inc.. Device class: 2.

Clearance details

Applicant: Hemotec, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1984-09-05
Decision date: 1984-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

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