K890051 is an FDA 510(k) clearance for the BIOTRACK APTT CONTROLS. This device is classified as a Reagent & Control, Partial Thromboplastin Time (Class II - Special Controls, product code GIT).
Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 23, 1989, 48 days after receiving the submission on January 6, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K890051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1989 |
| Decision Date | February 23, 1989 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIT — Reagent & Control, Partial Thromboplastin Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |