The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem-chex Stat.
| Device ID | K961195 |
| 510k Number | K961195 |
| Device Name: | CHEM-CHEX STAT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Contact | Theodore Heise |
| Correspondent | Theodore Heise 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 | 1996-03-27 |
| Decision Date | 1996-05-15 |
| Summary: | summary |