The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Protime Controls (biotrack Protime Test).
| Device ID | K860719 |
| 510k Number | K860719 |
| Device Name: | BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BIOTRACK, INC. 430 OAKMEAD PKWY. Sunnyvale, CA 94086 |
| Contact | Jim Allen |
| Correspondent | Jim Allen BIOTRACK, INC. 430 OAKMEAD PKWY. Sunnyvale, CA 94086 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-26 |
| Decision Date | 1986-05-23 |