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 |