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.), Model 10759350 360.
| Device ID | K062319 |
| 510k Number | K062319 |
| Device Name: | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-09-13 |
| Summary: | summary |