The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem-chex Stat (new).
| Device ID | K982290 |
| 510k Number | K982290 |
| Device Name: | CHEM-CHEX STAT (NEW) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Contact | Paul Kittelson |
| Correspondent | Paul Kittelson STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1998-07-22 |
| Summary: | summary |