SERIM PYLORITEK TEST KIT— 510(k) K953632

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K953632 for SERIM PYLORITEK TEST KIT, Substantially Equivalent on 1995-12-18. Applicant: Serim Research Corp..

Clearance details

Applicant: Serim Research Corp.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1995-07-20
Decision date: 1995-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, 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.