FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTHROMBIN TIME TEST CARD
K Number: K954625
·
Decision Mar 11, 1996
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
13
Review Days
166
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Basic Information
- Device Name
- PROTHROMBIN TIME TEST CARD
- K Number
- K954625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiovascular Diagnostics, Inc.
- Date Received
- September 27, 1995
- Decision Date
- March 11, 1996
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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Other Clearances by Cardiovascular Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013305 | ENOXAPARIN TEST CARD | Aug 23, 2002 | Substantially Equivalent |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Mar 28, 2000 | Substantially Equivalent |
| K994159 | HMP CONTROLS (TAS) RAPIDPOINT | Feb 15, 2000 | Substantially Equivalent |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Jan 14, 2000 | Substantially Equivalent |
| K990566 | TAS ANALYZER, MODEL 1009 | May 14, 1999 | Substantially Equivalent |
| K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | May 26, 1998 | Substantially Equivalent |
| K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS | Apr 27, 1998 | Substantially Equivalent |
| K971748 | TAS PT-NCTEST CONTROLS | May 29, 1997 | Substantially Equivalent |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Aug 13, 1996 | Substantially Equivalent |
| K961189 | TAS A PTT TEST CONTROLS | Jun 5, 1996 | Substantially Equivalent |