The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Calibrator For Automatic Systems (cfas).
Device ID | K033501 |
510k Number | K033501 |
Device Name: | MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Contact | Sherri L Coenen |
Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-05 |
Decision Date | 2003-11-20 |
Summary: | summary |