DeviceClearance

K251697

Substantially Equivalent

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Applicant
ACON Laboratories, Inc.
Product code
GTY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GTY

product code GTY
Death
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.