The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem-chex Bilirubin.
| Device ID | K902867 |
| 510k Number | K902867 |
| Device Name: | CHEM-CHEX BILIRUBIN |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Halvor Sornson |
| Correspondent | Halvor Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-29 |
| Decision Date | 1990-07-16 |