CELL-CHEX
Mixture, Control, White-cell And Red-cell Indices
Streck
The following data is part of a premarket notification filed by Streck with the FDA for Cell-chex.
Pre-market Notification Details
| Device ID | K101335 |
| 510k Number | K101335 |
| Device Name: | CELL-CHEX |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Kerrie Oetter |
| Correspondent | Kerrie Oetter Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-12 |
| Decision Date | 2010-08-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000303 | K101335 | 000 |
| 00844509000297 | K101335 | 000 |
| 00844509000280 | K101335 | 000 |
| 30844509000267 | K101335 | 000 |
| 20844509000277 | K101335 | 000 |
| 20844509000260 | K101335 | 000 |
| 20844509000253 | K101335 | 000 |
Trademark Results [CELL-CHEX]
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 |
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