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FDA 510(k)

PYLORI DETECT IGG

K-Number: K973508 · 1998-03-10

ApplicantMicro Detect, Inc.
Decision Date1998-03-10
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORI DETECT IGG is the device name listed in this FDA 510(k) record. The listed applicant is Micro Detect, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K973508. 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 PYLORI DETECT IGG?

PYLORI DETECT IGG is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Micro Detect, Inc.. The 510(k) number is K973508.

When did PYLORI DETECT IGG receive FDA 510(k) clearance?

PYLORI DETECT IGG received FDA 510(k) clearance on 1998-03-10, under 510(k) number K973508.

Who is the listed applicant for PYLORI DETECT IGG?

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

What is the FDA product code for PYLORI DETECT IGG?

The FDA product code for PYLORI DETECT IGG is LYR.

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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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