The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Hemoglobin Test Cartridge.
| Device ID | K895101 |
| 510k Number | K895101 |
| Device Name: | BIOTRACK HEMOGLOBIN TEST CARTRIDGE |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Contact | Jill Findlay |
| Correspondent | Jill Findlay BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-10-10 |