THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS— 510(k) K981178
Substantially EquivalentCardiovascular 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.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Diagnostics, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
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More clearances from Cardiovascular Diagnostics, Inc.
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