The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron(r) Kact.
| Device ID | K913861 |
| 510k Number | K913861 |
| Device Name: | HEMOCHRON(R) KACT |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Matt Lesnieski |
| Correspondent | Matt Lesnieski INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-27 |
| Decision Date | 1991-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234101391 | K913861 | 000 |