The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Vitamin B12 Immunoassay, Calset Ii And Calcheck.
| Device ID | K060755 |
| 510k Number | K060755 |
| Device Name: | ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK |
| Classification | Radioassay, Vitamin B12 |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Contact | Randy J Johnson |
| Correspondent | Randy J Johnson ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Product Code | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630939428 | K060755 | 000 |