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FDA 510(k)

ACCUSTAT H. PYLORI ONE STEP TEST

K-Number: K973523 · 1998-03-03

ApplicantBoehringer Mannheim Corp.
Decision Date1998-03-03
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUSTAT H. PYLORI ONE STEP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K973523. 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 ACCUSTAT H. PYLORI ONE STEP TEST?

ACCUSTAT H. PYLORI ONE STEP TEST is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K973523.

When did ACCUSTAT H. PYLORI ONE STEP TEST receive FDA 510(k) clearance?

ACCUSTAT H. PYLORI ONE STEP TEST received FDA 510(k) clearance on 1998-03-03, under 510(k) number K973523.

Who is the listed applicant for ACCUSTAT H. PYLORI ONE STEP TEST?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSTAT H. PYLORI ONE STEP TEST?

The FDA product code for ACCUSTAT H. PYLORI ONE STEP TEST 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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