The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Jr. Signature +.
| Device ID | K020798 |
| 510k Number | K020798 |
| Device Name: | HEMOCHRON JR. SIGNATURE + |
| 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 | 2002-03-12 |
| Decision Date | 2002-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950088523 | K020798 | 000 |
| 08426950088516 | K020798 | 000 |
| 10711234540107 | K020798 | 000 |
| 10711234540091 | K020798 | 000 |
| 10711234540084 | K020798 | 000 |
| 10711234540077 | K020798 | 000 |