DeviceClearance

BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST— 510(k) K980798

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K980798 for BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST, Substantially Equivalent on 1998-09-22. Applicant: Princeton BioMeditech Corp.. Device class: 1.

Clearance details

Applicant
Princeton BioMeditech Corp.
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
Monmouth Junction, NJ, 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 →

Recalls naming K980798

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980798.

Data sourced from openFDA. This site is unofficial and independent of the FDA.