The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem-chex Lipid.
| Device ID | K905389 |
| 510k Number | K905389 |
| Device Name: | CHEM-CHEX LIPID |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Contact | Halvor C Sornson |
| Correspondent | Halvor C Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1990-12-26 |