The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Calcium Gen. 2.
| Device ID | K113521 |
| 510k Number | K113521 |
| Device Name: | CALCIUM GEN. 2 |
| Classification | Titrimetric With Edta And Indicator, Calcium |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Lisa K Klinedinst |
| Correspondent | Lisa K Klinedinst Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | CHW |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-29 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121092 | K113521 | 000 |
| 04015630924936 | K113521 | 000 |
| 04015630924042 | K113521 | 000 |
| 04015630924035 | K113521 | 000 |
| 04015630924004 | K113521 | 000 |
| 04015630923991 | K113521 | 000 |