The following data is part of a premarket notification filed by Streck with the FDA for Cyto-chex Bct.
| Device ID | K080552 |
| 510k Number | K080552 |
| Device Name: | CYTO-CHEX BCT |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Carl Thompson |
| Correspondent | Carl Thompson Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40844509002206 | K080552 | 000 |
| 40844509000837 | K080552 | 000 |
| 30844509002209 | K080552 | 000 |
| 30844509000830 | K080552 | 000 |
| 30844509000823 | K080552 | 000 |
| 20844509002202 | K080552 | 000 |
| 20844509000833 | K080552 | 000 |
| 20844509000826 | K080552 | 000 |