The following data is part of a premarket notification filed by Chemtrak, Inc. with the FDA for Accumeter(r) Cholesterol Self-test.
| Device ID | K914432 |
| 510k Number | K914432 |
| Device Name: | ACCUMETER(R) CHOLESTEROL SELF-TEST |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale, CA 94086 |
| Contact | Erika Ammirati |
| Correspondent | Erika Ammirati CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale, CA 94086 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-04 |
| Decision Date | 1993-03-02 |