THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS— 510(k) K981178

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K981178 for THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS, Substantially Equivalent on 1998-04-27. Applicant: Cardiovascular Diagnostics, Inc..

Clearance details

Applicant
Cardiovascular Diagnostics, Inc.
Product code
Code GGN
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raleigh, NC, US
Download summary PDFView on FDA.gov ↗

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