The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron(r) Prothrombin Time/modification.
| Device ID | K904454 |
| 510k Number | K904454 |
| Device Name: | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-12-17 |