The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Chem Chex Theophylline Control.
| Device ID | K920223 |
| 510k Number | K920223 |
| Device Name: | CHEM CHEX THEOPHYLLINE CONTROL |
| Classification | Theophylline Control Materials |
| 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 | LAW |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-17 |
| Decision Date | 1992-06-10 |