FDA 510(k) Applications Submitted by ROGER ALBESA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190088 |
01/17/2019 |
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents |
Inova Diagnostics, Inc. |
| K170993 |
04/03/2017 |
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
Inova Diagnostics, Inc. |
| K180971 |
04/13/2018 |
QUANTA Flash Calprotectin and Fecal Extraction Device |
Inova Diagnostics, Inc. |
| K180975 |
04/13/2018 |
QUANTA Flash HMGCR Reagents |
Inova Diagnostics, Inc. |
| K141274 |
05/16/2014 |
QUANTA FLASH ┐2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-┐2GPI DOMAIN1; CONTROLS. |
INOVA DIAGNOSTICS, INC. |
| K163538 |
12/16/2016 |
QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls |
INOVA DIAGNOSTICS, INC. |
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