The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Bio-lipid Lipid Control- Level 1,2 And 3.
| Device ID | K951749 |
| 510k Number | K951749 |
| Device Name: | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. Rancho Dominguez, CA 90220 -6411 |
| Contact | Marc M Mckonic |
| Correspondent | Marc M Mckonic BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. Rancho Dominguez, CA 90220 -6411 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011848 | K951749 | 000 |
| 00817439021045 | K951749 | 000 |