The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Aptt Reagent Cartridge.
| Device ID | K890052 |
| 510k Number | K890052 |
| Device Name: | BIOTRACK APTT REAGENT CARTRIDGE |
| Classification | Activated Partial Thromboplastin |
| Applicant | BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Contact | Laura Winfrey |
| Correspondent | Laura Winfrey BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-06 |
| Decision Date | 1989-02-24 |