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FDA 510(k)

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

K-Number: K052716 · 2006-11-16

ApplicantOtsuka Pharmaceutical Co., Ltd.
Decision Date2006-11-16
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2006-11-16 under 510(k) number K052716. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIRUN H. PYLORI ANTIBODY DETECTION KIT?

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT is a medical device that received FDA 510(k) clearance on 2006-11-16. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. The 510(k) number is K052716.

When did RAPIRUN H. PYLORI ANTIBODY DETECTION KIT receive FDA 510(k) clearance?

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT received FDA 510(k) clearance on 2006-11-16, under 510(k) number K052716.

Who is the listed applicant for RAPIRUN H. PYLORI ANTIBODY DETECTION KIT?

The FDA 510(k) record lists Otsuka Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIRUN H. PYLORI ANTIBODY DETECTION KIT?

The FDA product code for RAPIRUN H. PYLORI ANTIBODY DETECTION KIT is LYR.

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Other records listing Otsuka Pharmaceutical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LYR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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