510(k) K910105
- Device
- PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
- Applicant
- INTERNATIONAL TECHNIDYNE CORP.
- 510(k) number
- K910105
- Product code
- GFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-26
- Date received
- 1991-01-03
- Regulation
- 864.7525
- Classification name
- Protamine Sulphate
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LES HEIMANN
- Address
- 23 Nevsky St. Edison NJ US 08820 08820
FDA Registration Numbers#
- 3002721930
- 2184009
- 1217183
- 1718389
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944115 | HEPARIN ASSAY CARTRIDGES AND CONTROLS | Medtronic Hemotec, Inc. | 1995-03-24 |
Legacy Summary#
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FDA Review#
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