The following data is part of a premarket notification filed by Streck with the FDA for Cell-chex Auto.
| Device ID | K053362 |
| 510k Number | K053362 |
| Device Name: | CELL-CHEX AUTO |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000600 | K053362 | 000 |
| 00844509000594 | K053362 | 000 |
| 00844509000587 | K053362 | 000 |
| 20844509000574 | K053362 | 000 |
| 20844509000567 | K053362 | 000 |
| 20844509000550 | K053362 | 000 |