The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Aptt By Hemochron(r).
| Device ID | K892209 |
| 510k Number | K892209 |
| Device Name: | APTT BY HEMOCHRON(R) |
| Classification | Activated Partial Thromboplastin |
| Applicant | INTENSIVE TECHNOLOGY, INC. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Les Heimann |
| Correspondent | Les Heimann INTENSIVE TECHNOLOGY, INC. 23 NEVSKY ST. 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 | 1989-04-03 |
| Decision Date | 1989-06-22 |