The following data is part of a premarket notification filed by Chemtrak, Inc. with the FDA for Accumeter Hdl Cholesterol Test.
| Device ID | K943279 |
| 510k Number | K943279 |
| Device Name: | ACCUMETER HDL CHOLESTEROL TEST |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale, CA 94086 |
| Contact | Jill Findlay |
| Correspondent | Jill Findlay CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale, CA 94086 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1995-05-01 |