BIOCLEAN CHEMO SHIELD— 510(k) K081970

Substantially Equivalent

Nitritex (M) Sdn. Bhd.

FDA 510(k) clearance K081970 for BIOCLEAN CHEMO SHIELD, Substantially Equivalent on 2009-03-11. Applicant: Nitritex (M) Sdn. Bhd..

Clearance details

Applicant: Nitritex (M) Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2008-07-10
Decision date: 2009-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuala Langat, Selangor De, MY

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Adverse events under product code LZA

product code LZA

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.