The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cell-chex.
Device ID | K000076 |
510k Number | K000076 |
Device Name: | CELL-CHEX |
Classification | Control, Red-cell |
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 | GJR |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-10 |
Decision Date | 2000-03-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CELL-CHEX 85410938 4166939 Live/Registered |
Streck, Inc. 2011-08-30 |
CELL-CHEX 78700736 not registered Dead/Abandoned |
Streck Laboratories, Inc. 2005-08-25 |
CELL-CHEX 77818922 not registered Dead/Abandoned |
Streck, Inc. 2009-09-02 |
CELL-CHEX 73024278 1027707 Dead/Expired |
STRECK LABORATORIES, INC. 1974-06-14 |