The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Coaguchek Xs System.
Device ID | K062925 |
510k Number | K062925 |
Device Name: | COAGUCHEK XS SYSTEM |
Classification | Test, Time, Prothrombin |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
Contact | Theresa Bush |
Correspondent | Theresa Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
Product Code | GJS |
CFR Regulation Number | 864.7750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-28 |
Decision Date | 2007-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00365702127104 | K062925 | 000 |
00365702125100 | K062925 | 000 |
04015630945689 | K062925 | 000 |