DeviceClearance

K971349

Substantially Equivalent

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

Applicant
Princeton BioMeditech Corp.
Product code
GTY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monmouth Junction, NJ, 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.