The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Cobas C Acetaminophen Gen.2 Assay, Acet2 Calibrator.
| Device ID | K141928 |
| 510k Number | K141928 |
| Device Name: | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Noel K Mencias |
| Correspondent | Noel K Mencias Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336120934 | K141928 | 000 |
| 04015630935031 | K141928 | 000 |