HEMOCHRON RESPONSE
FDA 510(k) clearance K983475 · decided 1999-05-03
Clearance details
- K-number
- K983475
- Device name
- HEMOCHRON RESPONSE
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-02
- Decision date
- 1999-05-03
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- KQG
- Device class
- 2
- Regulation number
- 864.5400
- 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 Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label sta recall (Z-1093-2011) | International Technidyne Corp. | 2011-02-11 |