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 |