The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Lh Calcheck 5.
| Device ID | K121279 |
| 510k Number | K121279 |
| Device Name: | ELECSYS LH CALCHECK 5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | K. Colleen Adams |
| Correspondent | K. Colleen Adams Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-05-10 |
| Summary: | summary |