The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Stak-chex.
| Device ID | K911582 |
| 510k Number | K911582 |
| Device Name: | STAK-CHEX |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Contact | Halvor Sornson |
| Correspondent | Halvor Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. Omaha, NE 68144 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001188 | K911582 | 000 |
| 00844509001171 | K911582 | 000 |
| 30844509001158 | K911582 | 000 |
| 20844509001168 | K911582 | 000 |
| 20844509001151 | K911582 | 000 |
| 20844509001144 | K911582 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STAK-CHEX 75623750 2335221 Live/Registered |
STRECK, INC. 1999-01-19 |
![]() STAK-CHEX 74266212 1742704 Dead/Cancelled |
STRECK LABORATORIES, INC. 1992-04-16 |