The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Protime Microcoagulation System / Protime 3 Cuvette.
| Device ID | K010599 |
| 510k Number | K010599 |
| Device Name: | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE |
| Classification | Test, Time, Prothrombin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-28 |
| Decision Date | 2001-07-02 |