The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Calibrator For Automated Systems Prealbumin-aslo-ceruloplasmin (c.f.a.s. Pac).
Device ID | K040245 |
510k Number | K040245 |
Device Name: | CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Contact | Theresa M Ambrose |
Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-03 |
Decision Date | 2004-03-24 |
Summary: | summary |