RAPIDTEG TEG-ACT TEST— 510(k) K062604

Substantially Equivalent

Haemoscope Corp.

FDA 510(k) clearance K062604 for RAPIDTEG TEG-ACT TEST, Substantially Equivalent on 2007-01-31. Applicant: Haemoscope Corp.. Device class: 2.

Clearance details

Applicant: Haemoscope Corp.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 2006-09-01
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Download summary PDF View on FDA.gov ↗

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