QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS— 510(k) K972146

Substantially Equivalent

Consolidated Technologies, Inc.

FDA 510(k) clearance K972146 for QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS, Substantially Equivalent on 1997-07-08. Applicant: Consolidated Technologies, Inc..

Clearance details

Applicant: Consolidated Technologies, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1997-06-09
Decision date: 1997-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.