The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Bio-lipid Human Serum Hdl And Ldl Calibrators.
| Device ID | K000056 |
| 510k Number | K000056 |
| Device Name: | BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-02-24 |