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FDA 510(k)

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

K-Number: K001177 · 2000-11-13

ApplicantEnteric Products, Inc.
Decision Date2000-11-13
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is Enteric Products, Inc.. It received FDA 510(k) clearance on 2000-11-13 under 510(k) number K001177. 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 PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI?

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Enteric Products, Inc.. The 510(k) number is K001177.

When did PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI receive FDA 510(k) clearance?

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI received FDA 510(k) clearance on 2000-11-13, under 510(k) number K001177.

Who is the listed applicant for PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI?

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

What is the FDA product code for PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI?

The FDA product code for PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI is LYR.

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Other records listing Enteric Products, Inc. as applicant

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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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