The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecys Hgh Calset, Elecsys Hgh Calcheck 5.
| Device ID | K103221 |
| 510k Number | K103221 |
| Device Name: | ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 |
| Classification | Calibrator, Secondary |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Kelly C O'maine Adams |
| Correspondent | Kelly C O'maine Adams Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630926671 | K103221 | 000 |