DeviceClearance

QUANTAI UG REAGENT STRIP— 510(k) K893661

Substantially Equivalent

Quantai Biotronics, Inc.

FDA 510(k) clearance K893661 for QUANTAI UG REAGENT STRIP, Substantially Equivalent on 1989-11-08. Applicant: Quantai Biotronics, Inc..

Clearance details

Applicant
Quantai Biotronics, Inc.
Product code
Code CGA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tustin, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CGA

product code CGA
Death
2
Malfunction
1,816
Total
1,818

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.