DeviceClearance

H. PYLORI QUIK CHEK— 510(k) K181379

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K181379 for H. PYLORI QUIK CHEK, Substantially Equivalent on 2018-08-21. Applicant: Techlab, Inc..

Clearance details

Applicant
Techlab, Inc.
Product code
Code LYR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Blacksburg, VA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LYR

product code LYR
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.