The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Microcoagulation Prothrombin Time Test.
| Device ID | K940432 |
| 510k Number | K940432 |
| Device Name: | MICROCOAGULATION PROTHROMBIN TIME TEST |
| 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 | 1994-01-31 |
| Decision Date | 1994-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234103036 | K940432 | 000 |