510(k) K944115
- Device
- HEPARIN ASSAY CARTRIDGES AND CONTROLS
- Applicant
- MEDTRONIC HEMOTEC, INC.
- 510(k) number
- K944115
- Product code
- GFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-24
- Date received
- 1994-08-23
- Regulation
- 864.7525
- Classification name
- Protamine Sulphate
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT F BAUGH
- Address
- 7103 S. Revere Pkwy. Englewood CO US 80112 80112
FDA Registration Numbers#
- 3002721930
- 2184009
- 1217183
- 1718389
Source Documents#
Other 510(k) Records For Product Code GFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | International Technidyne Corp. | 1991-02-26 |
Legacy Summary#
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FDA Review#
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