The following data is part of a premarket notification filed by Dako A/s with the FDA for Cystatin C Immunoparticles, Control Set, Calibrator.
| Device ID | K041627 |
| 510k Number | K041627 |
| Device Name: | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR |
| Classification | Test, Cystatin C |
| Applicant | DAKO A/S 42 PRODUKTIONSVEJ Glostrup, DK Dk-2600 |
| Contact | Dana Olsen |
| Correspondent | Dana Olsen DAKO A/S 42 PRODUKTIONSVEJ Glostrup, DK Dk-2600 |
| Product Code | NDY |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-16 |
| Decision Date | 2004-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700572014294 | K041627 | 000 |
| 05700572014287 | K041627 | 000 |
| 05700572013853 | K041627 | 000 |