The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas 8000 Modular Series Analyzer.
| Device ID | K100853 |
| 510k Number | K100853 |
| Device Name: | COBAS 8000 MODULAR SERIES ANALYZER |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DCF |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHN |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJW |
| Subsequent Product Code | CJX |
| Subsequent Product Code | CZP |
| Subsequent Product Code | CZW |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336142578 | K100853 | 000 |
| 04015630946341 | K100853 | 000 |
| 04015630930845 | K100853 | 000 |
| 04015630928354 | K100853 | 000 |