The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Jr. Miocrocoagulation Citrated Pt.
| Device ID | K972866 |
| 510k Number | K972866 |
| Device Name: | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT |
| Classification | Test, Time, Prothrombin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Contact | Robert H Matland |
| Correspondent | Robert H Matland INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. 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 | 1997-08-04 |
| Decision Date | 1998-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234103043 | K972866 | 000 |