The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Hnpt/factor Vi Pt+.
| Device ID | K945078 |
| 510k Number | K945078 |
| Device Name: | HEMOCHRON HNPT/FACTOR VI PT+ |
| Classification | Test, Time, Prothrombin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Robert N Borghese |
| Correspondent | Robert N Borghese INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-17 |
| Decision Date | 1995-04-28 |