SELECTIVE RAPID UREA— 510(k) K883641

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K883641 for SELECTIVE RAPID UREA, Substantially Equivalent on 1989-05-04. Applicant: Remel Co..

Clearance details

Applicant: Remel Co.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1988-08-25
Decision date: 1989-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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.