The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Creatinine Plus Ver.2 Assay.
Device ID | K024098 |
510k Number | K024098 |
Device Name: | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY |
Classification | Enzymatic Method, Creatinine |
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 | JFY |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-12 |
Decision Date | 2002-12-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613336121160 | K024098 | 000 |