The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Calibrator For Automated Systems (c.f.a.s.) Proteins With Model 11355279160.
| Device ID | K080607 |
| 510k Number | K080607 |
| Device Name: | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -3831 |
| Contact | Kathie J Cunningham |
| Correspondent | Kathie J Cunningham ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -3831 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-05-12 |