JR. MICROCOAGULATION SYSTEM
FDA 510(k) clearance K940401 · decided 1994-05-11
Clearance details
- K-number
- K940401
- Device name
- JR. MICROCOAGULATION SYSTEM
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-27
- Decision date
- 1994-05-11
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic co recall (Z-2088-2014) | ITC-Nexus Dx | 2014-07-21 |