DeviceClearance

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI— 510(k) K001177

Substantially Equivalent

Enteric Products, Inc.

FDA 510(k) clearance K001177 for PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI, Substantially Equivalent on 2000-11-13. Applicant: Enteric Products, Inc.. Device class: 1.

Clearance details

Applicant
Enteric Products, 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
Stony Brook, NY, 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.