RETIC-CHEX
Mixture, Hematology Quality Control
STRECK LABORATORIES, INC.
The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Retic-chex.
Pre-market Notification Details
| Device ID | K905524 |
| 510k Number | K905524 |
| Device Name: | RETIC-CHEX |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1991-02-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414224442 | K905524 | 000 |
| 00630414224428 | K905524 | 000 |
Trademark Results [RETIC-CHEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETIC-CHEX 73710533 1510645 Live/Registered |
STRECK LABORATORIES, INC. 1988-02-10 |
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