The following data is part of a premarket notification filed by Streck with the FDA for Stak-chex Plus Retics.
| Device ID | K090137 |
| 510k Number | K090137 |
| Device Name: | STAK-CHEX PLUS RETICS |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| 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 | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000365 | K090137 | 000 |
| 00844509000358 | K090137 | 000 |
| 30844509000335 | K090137 | 000 |
| 20844509000345 | K090137 | 000 |
| 20844509000338 | K090137 | 000 |
| 20844509000321 | K090137 | 000 |