PYLORI DETECT IGG— 510(k) K973508

Substantially Equivalent

Micro Detect, Inc.

FDA 510(k) clearance K973508 for PYLORI DETECT IGG, Substantially Equivalent on 1998-03-10. Applicant: Micro Detect, Inc..

Clearance details

Applicant: Micro Detect, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1997-09-16
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.