FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-1 PT-NC TEST CARD
K Number: K904325
·
Decision Jan 25, 1991
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
8
Review Days
127
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Basic Information
- Device Name
- COAG-1 PT-NC TEST CARD
- K Number
- K904325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cardiovascular Diagnostic Services
- Date Received
- September 20, 1990
- Decision Date
- January 25, 1991
- 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 Diagnostic Services
| K Number | Device Name | ||
|---|---|---|---|
| K955843 | TAS PTONE | Mar 18, 1996 | Substantially Equivalent |
| K933092 | TAS ANALYZER | Nov 15, 1993 | Substantially Equivalent |
| K903019 | MODIFIED COAG-1 PT TEST CARD | Aug 1, 1990 | Substantially Equivalent |
| K891015 | COAG-1 APTT TEST CARD | May 22, 1989 | Substantially Equivalent |
| K882444 | COAG-I ANALYZER, ALPHA MODEL | Aug 25, 1988 | Substantially Equivalent |
| K882456 | COAG-I PT TEST CARD | Aug 25, 1988 | Substantially Equivalent |
| K812304 | DORROS-SPRING PRESSURIZER | Oct 13, 1981 | Substantially Equivalent |