The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Response/system.
| Device ID | K030818 |
| 510k Number | K030818 |
| Device Name: | HEMOCHRON RESPONSE/SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-04-02 |
| Summary: | summary |