FDA 510(k)

QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS

K-Number: K972146 · 1997-07-08

ApplicantConsolidated Technologies, Inc.

Decision Date1997-07-08

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technologies, Inc.. It received FDA 510(k) clearance on 1997-07-08 under 510(k) number K972146. 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 QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS?

QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K972146.

When did QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS receive FDA 510(k) clearance?

QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS received FDA 510(k) clearance on 1997-07-08, under 510(k) number K972146.

Who is the listed applicant for QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS?

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

What is the FDA product code for QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS?

The FDA product code for QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS is LYR.

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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.