SUGAR-CHEX
Single (specified) Analyte Controls (assayed And Unassayed)
STRECK LABORATORIES, INC.
The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Sugar-chex.
Pre-market Notification Details
| Device ID | K851042 |
| 510k Number | K851042 |
| Device Name: | SUGAR-CHEX |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137 |
| Contact | Halvor Sornson |
| Correspondent | Halvor Sornson STRECK LABORATORIES, INC. P.O. BOX 37625 Omaha, NE 68137 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-04-29 |
Trademark Results [SUGAR-CHEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUGAR-CHEX 74157012 1726948 Live/Registered |
STRECK, INC. 1991-04-15 |
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