The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas 6000 Series System.
| Device ID | K060373 |
| 510k Number | K060373 |
| Device Name: | COBAS 6000 SERIES SYSTEM |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CZW |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| Subsequent Product Code | KNK |
| Subsequent Product Code | LDP |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630946402 | K060373 | 000 |
| 07613336227770 | K060373 | 000 |
| 07613336227787 | K060373 | 000 |
| 07613336227794 | K060373 | 000 |
| 04015630924714 | K060373 | 000 |
| 04015630938551 | K060373 | 000 |
| 04015630938568 | K060373 | 000 |
| 04015630902682 | K060373 | 000 |
| 04015630915064 | K060373 | 000 |
| 07613336133590 | K060373 | 000 |
| 04015630924707 | K060373 | 000 |
| 04015630925551 | K060373 | 000 |
| 07613336227763 | K060373 | 000 |