The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecys Anti-ccp Calcheck.
| Device ID | K091601 |
| 510k Number | K091601 |
| Device Name: | ELECYS ANTI-CCP CALCHECK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BOX 50410 Indianapolis, IN 46250 -0457 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BOX 50410 Indianapolis, IN 46250 -0457 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-09-25 |
| Summary: | summary |