The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Electronic System Verification Tube.
| Device ID | K990449 |
| 510k Number | K990449 |
| Device Name: | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234540060 | K990449 | 000 |
| 10711234540053 | K990449 | 000 |
| 10711234540114 | K990449 | 000 |