The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex.
| Device ID | K920997 |
| 510k Number | K920997 |
| Device Name: | CD-CHEX |
| Classification | Control, White-cell |
| 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 | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-05-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CD-CHEX 85734336 not registered Dead/Abandoned |
Streck, Inc. 2012-09-20 |
![]() CD-CHEX 74294040 1757960 Dead/Cancelled |
STRECK, INC. 1992-07-14 |