The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Hitachi Bicarbonate Liquid.
Device ID | K032377 |
510k Number | K032377 |
Device Name: | ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID |
Classification | Enzymatic, Carbon-dioxide |
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 | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-01 |
Decision Date | 2003-08-21 |
Summary: | summary |