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FDA 510(k)

PYLORIPROBE

K-Number: K981396 · 1998-07-30

ApplicantAmdl, Inc.
Decision Date1998-07-30
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORIPROBE is the device name listed in this FDA 510(k) record. The listed applicant is Amdl, Inc.. It received FDA 510(k) clearance on 1998-07-30 under 510(k) number K981396. 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 PYLORIPROBE?

PYLORIPROBE is a medical device that received FDA 510(k) clearance on 1998-07-30. The listed applicant is Amdl, Inc.. The 510(k) number is K981396.

When did PYLORIPROBE receive FDA 510(k) clearance?

PYLORIPROBE received FDA 510(k) clearance on 1998-07-30, under 510(k) number K981396.

Who is the listed applicant for PYLORIPROBE?

The FDA 510(k) record lists Amdl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYLORIPROBE?

The FDA product code for PYLORIPROBE is LYR.

Related Clinical Trials

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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Other records listing Amdl, Inc. 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.

K072901AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101

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

View on FDA Database →

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

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