The following data is part of a premarket notification filed by Streck with the FDA for Cell-dyn 22 Plus Calibrator.
| Device ID | K111204 |
| 510k Number | K111204 |
| Device Name: | CELL-DYN 22 PLUS CALIBRATOR |
| Classification | Calibrator For Cell Indices |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Deborah Kipp |
| Correspondent | Deborah Kipp Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | KRX |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740119843 | K111204 | 000 |