The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cal-chex Cd Plus.
| Device ID | K020469 |
| 510k Number | K020469 |
| Device Name: | CAL-CHEX CD PLUS |
| Classification | Calibrator For Cell Indices |
| Applicant | STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Contact | Paul Kittelson |
| Correspondent | Paul Kittelson STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Product Code | KRX |
| Subsequent Product Code | KRY |
| Subsequent Product Code | KRZ |
| Subsequent Product Code | KSA |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740017071 | K020469 | 000 |
| 40844509000318 | K020469 | 000 |
| 30844509000311 | K020469 | 000 |
| 20844509000314 | K020469 | 000 |
| 00380740151294 | K020469 | 000 |