APTT BY HEMOCHRON(R)— 510(k) K892209

Name: FDA 510(k) clearance K892209
Creator: U.S. Food and Drug Administration
Published: 1989-06-22

Substantially Equivalent

Intensive Technology, Inc.

FDA 510(k) clearance K892209 for APTT BY HEMOCHRON(R), Substantially Equivalent on 1989-06-22. Applicant: Intensive Technology, Inc.. Device class: 2.

Clearance details

Applicant: Intensive Technology, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-04-03
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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