The following data is part of a premarket notification filed by Streck with the FDA for E-check (xe).
| Device ID | K063218 |
| 510k Number | K063218 |
| Device Name: | E-CHECK (XE) |
| 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 | 2006-10-24 |
| Decision Date | 2006-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987562460295 | K063218 | 000 |