HEPARIN ASSAY CARTRIDGES AND CONTROLS
FDA 510(k) clearance K944115 · decided 1995-03-24
Clearance details
- K-number
- K944115
- Device name
- HEPARIN ASSAY CARTRIDGES AND CONTROLS
- Applicant
- Medtronic Hemotec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-23
- Decision date
- 1995-03-24
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- GFT
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 (K910105) | International Technidyne Corp. | 1991-02-26 |
Recalls involving this device
No recalls on record reference this clearance.