The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Thrombochronometer.
| Device ID | K832189 |
| 510k Number | K832189 |
| Device Name: | HEMOCHRON THROMBOCHRONOMETER |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-08 |
| Decision Date | 1983-10-14 |