K012995

Substantially Equivalent

COLLATEK SHEET

Applicant
Biocore Medical Technologies, Inc.
Product code
MGP
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Silver Spring, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MGP

product code MGP
Other
1
Total
1

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.