The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Direct Ldl Cholesterol, Model L530-60h.
Device ID | K051121 |
510k Number | K051121 |
Device Name: | DIRECT LDL CHOLESTEROL, MODEL L530-60H |
Classification | System, Test, Low Density, Lipoprotein |
Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
Contact | Jian Vaeches |
Correspondent | Jian Vaeches TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
Product Code | MRR |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-02 |
Decision Date | 2005-08-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10673486002010 | K051121 | 000 |