The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Citrate Aptt.
| Device ID | K972831 |
| 510k Number | K972831 |
| Device Name: | HEMOCHRON CITRATE APTT |
| Classification | Activated Partial Thromboplastin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Contact | Robert H Matland |
| Correspondent | Robert H Matland INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-30 |
| Decision Date | 1997-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950915676 | K972831 | 000 |
| 10711234103029 | K972831 | 000 |