The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Response.
| Device ID | K983475 |
| 510k Number | K983475 |
| Device Name: | HEMOCHRON RESPONSE |
| Classification | Instrument, Coagulation |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Contact | John M Clay |
| Correspondent | John M Clay INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-02 |
| Decision Date | 1999-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234520062 | K983475 | 000 |
| 10711234520055 | K983475 | 000 |
| 10711234520017 | K983475 | 000 |