PYLORI-G FIAX TEST KIT— 510(k) K905468

Name: FDA 510(k) clearance K905468
Creator: U.S. Food and Drug Administration
Published: 1991-05-07

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K905468 for PYLORI-G FIAX TEST KIT, Substantially Equivalent on 1991-05-07. Applicant: Whittaker Bioproducts, Inc.. Device class: 1.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1990-12-06
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYR

view all

K232892 — Hp Detect Stool Antigen ELISA2023-12-15
K230901 — Premier HpSA Flex (619096)2023-07-03
K192817 — Curian HpSA, Curian Analyzer2020-03-13
K183573 — Vstrip H. pylori Antigen Rapid Test2019-03-14
K182559 — PREMIER Platinum HpSA PLUS2018-11-05

More clearances from Whittaker Bioproducts, Inc.

view all

K911356 — LEGIONELLA STAT IGG/IGM TEST KIT1992-07-30
K913212 — 3M IGE SINGLE POINT FAST TEST1991-11-22
K904652 — LYME STAT M TEST KIT1991-10-21
K904893 — FIAX LYME M TEST KIT1991-10-16
K911473 — EBNA STAT TEST KIT1991-09-25

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.