(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT— 510(k) K994194

Name: FDA 510(k) clearance K994194
Creator: U.S. Food and Drug Administration
Published: 2000-03-28

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K994194 for (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT, Substantially Equivalent on 2000-03-28. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascular Diagnostics, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1999-12-13
Decision date: 2000-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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