DeviceClearance

H. PYLORI CHEK— 510(k) K181400

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K181400 for H. PYLORI CHEK, Substantially Equivalent on 2018-08-21. Applicant: Techlab, Inc.. Device class: 1.

Clearance details

Applicant
Techlab, Inc.
Product code
Code LYR
Device class
Class 1
Regulation
21 CFR 866.3110
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Blacksburg, VA, US
Download summary PDFView on FDA.gov ↗

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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.