The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Retic-chex For Cell-dyn.
| Device ID | K042587 |
| 510k Number | K042587 |
| Device Name: | RETIC-CHEX FOR CELL-DYN |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Contact | Kerrie Oetter |
| Correspondent | Kerrie Oetter STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, 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 | 2004-09-22 |
| Decision Date | 2004-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740017149 | K042587 | 000 |