The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Tdm Amika.
Device ID | K032279 |
510k Number | K032279 |
Device Name: | ONLINE TDM AMIKA |
Classification | Amikacin Serum Assay |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Contact | Kerwin Kaufman |
Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Product Code | KLP |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-24 |
Decision Date | 2003-10-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613336133514 | K032279 | 000 |