The following data is part of a premarket notification filed by Streck with the FDA for Retic-chex Linearity For Bc.
| Device ID | K070199 |
| 510k Number | K070199 |
| Device Name: | RETIC-CHEX LINEARITY FOR BC |
| 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 | 2007-01-22 |
| Decision Date | 2007-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001133 | K070199 | 000 |