Cleared Traditional

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

K052716 · Otsuka Pharmaceutical Co., Ltd. · Microbiology
Nov 2006
Decision
413d
Days
Class 1
Risk

About This 510(k) Submission

K052716 is an FDA 510(k) clearance for the RAPIRUN H. PYLORI ANTIBODY DETECTION KIT, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on November 16, 2006, 413 days after receiving the submission on September 29, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K052716 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2005
Decision Date November 16, 2006
Days to Decision 413 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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