PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
FDA 510(k) clearance K910105 · decided 1991-02-26
Clearance details
- K-number
- K910105
- Device name
- PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-03
- Decision date
- 1991-02-26
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GFT
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, 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 |
|---|---|---|
| HEPARIN ASSAY CARTRIDGES AND CONTROLS (K944115) | Medtronic Hemotec, Inc. | 1995-03-24 |
Recalls involving this device
No recalls on record reference this clearance.