The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Rf Igm Reagents, Quanta Flash Rf Iga Reagents.
Device ID | K190088 |
510k Number | K190088 |
Device Name: | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents |
Classification | System, Test, Rheumatoid Factor |
Applicant | Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
Contact | Roger Albesa |
Correspondent | Roger Albesa Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-17 |
Decision Date | 2019-04-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08426950845249 | K190088 | 000 |
08426950835189 | K190088 | 000 |