The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Reflo-chex, A Cholesterol Reference Control.
| Device ID | K873105 |
| 510k Number | K873105 |
| Device Name: | REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137 |
| Contact | Hal Sornson |
| Correspondent | Hal Sornson STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-07 |
| Decision Date | 1987-09-16 |