The following data is part of a premarket notification filed by Streck with the FDA for Cd-chex Plus Bc.
| Device ID | K051633 |
| 510k Number | K051633 |
| Device Name: | CD-CHEX PLUS BC |
| Classification | Control, White-cell |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Carol Thompson |
| Correspondent | Carol Thompson Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000549 | K051633 | 000 |
| 00844509000532 | K051633 | 000 |
| 40844509000523 | K051633 | 000 |
| 40844509000516 | K051633 | 000 |
| 30844509000526 | K051633 | 000 |
| 30844509000519 | K051633 | 000 |
| 20844509000529 | K051633 | 000 |
| 20844509000512 | K051633 | 000 |