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 |