The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-hav Ii.
Device ID | K190428 |
510k Number | K190428 |
Device Name: | Elecsys Anti-HAV II |
Classification | Hepatitis A Test (antibody And Igm Antibody) |
Applicant | Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250 |
Contact | Jamie Ferguson |
Correspondent | Jamie Ferguson Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
Product Code | LOL |
CFR Regulation Number | 866.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-22 |
Decision Date | 2019-08-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613336129746 | K190428 | 000 |
07613336129722 | K190428 | 000 |
07613336129715 | K190428 | 000 |