The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Progesterone Iii Cal Check 5.
| Device ID | K150955 |
| 510k Number | K150955 |
| Device Name: | Elecsys Progesterone III Cal Check 5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Adam Clark |
| Correspondent | Adam Clark ROCHE DIAGNOSTICS ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-09 |
| Decision Date | 2015-05-01 |
| Summary: | summary |