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 |