The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas C Tina-quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset Lp (a) Gen 2 Califrator Set Model 05852641160.
| Device ID | K122722 |
| 510k Number | K122722 |
| Device Name: | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| 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 | DFC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-05 |
| Decision Date | 2012-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336140833 | K122722 | 000 |