HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
FDA 510(k) clearance K974799 · decided 1998-07-07
Clearance details
- K-number
- K974799
- Device name
- HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-22
- Decision date
- 1998-07-07
- Days to decision
- 197 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. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp recall (Z-2953-2011) | International Technidyne Corp. | 2011-08-05 |
| IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test recall (Z-2954-2011) | International Technidyne Corp. | 2011-08-05 |