DeviceClearance

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET— 510(k) K130157

Substantially Equivalent

Aalto Scientific, Ltd.

FDA 510(k) clearance K130157 for AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET, Substantially Equivalent on 2013-03-19. Applicant: Aalto Scientific, Ltd..

Clearance details

Applicant
Aalto Scientific, Ltd.
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.