CHEM-CHEX
Multi-analyte Controls, All Kinds (assayed)
STRECK LABORATORIES, INC.
The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem-chex.
Pre-market Notification Details
| Device ID | K913687 |
| 510k Number | K913687 |
| Device Name: | CHEM-CHEX |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Robert M Lachowiez |
| Correspondent | Robert M Lachowiez STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 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 | 1991-08-19 |
| Decision Date | 1991-09-19 |
Trademark Results [CHEM-CHEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHEM-CHEX 74211146 1732418 Dead/Cancelled |
STRECK, INC. 1991-10-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.