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FDA 510(k)

VARELISA HELICOBACTER PYLORI ANTIBODIES

K-Number: K953873 · 1996-08-30

ApplicantElias U.S.A., Inc.
Decision Date1996-08-30
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARELISA HELICOBACTER PYLORI ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1996-08-30 under 510(k) number K953873. 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 VARELISA HELICOBACTER PYLORI ANTIBODIES?

VARELISA HELICOBACTER PYLORI ANTIBODIES is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K953873.

When did VARELISA HELICOBACTER PYLORI ANTIBODIES receive FDA 510(k) clearance?

VARELISA HELICOBACTER PYLORI ANTIBODIES received FDA 510(k) clearance on 1996-08-30, under 510(k) number K953873.

Who is the listed applicant for VARELISA HELICOBACTER PYLORI ANTIBODIES?

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

What is the FDA product code for VARELISA HELICOBACTER PYLORI ANTIBODIES?

The FDA product code for VARELISA HELICOBACTER PYLORI ANTIBODIES is LYR.

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Other records listing Elias U.S.A., 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953586VARELISA PR3-ANCAK953587VARELISA MPO-ANCAK951187VARELISA CARDIOLIPIN ABS SCREENK944334VARELISA COMBINED DNA ANTIBODIES EIA

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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

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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