The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Protamine Response Test Catalogue Number Prt 200.
| Device ID | K910105 |
| 510k Number | K910105 |
| Device Name: | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 |
| Classification | Protamine Sulphate |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Les Heimann |
| Correspondent | Les Heimann INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | GFT |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-03 |
| Decision Date | 1991-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234202067 | K910105 | 000 |
| 10711234202050 | K910105 | 000 |
| 10711234102183 | K910105 | 000 |