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Stat-Sure Diagnostic Systems, Inc.

FDA Regulatory Profile

Stat-Sure Diagnostic Systems, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 25, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 25, 2025Brooklyn, NYDevicesNo Action Indicated (NAI)3008264082
Jul 11, 2022Brooklyn, NYDevicesNo Action Indicated (NAI)3008264082
Mar 13, 2018Brooklyn, NYDevicesNo Action Indicated (NAI)3008264082
Feb 24, 2011Brooklyn, NYDevicesNo Action Indicated (NAI)3008264082

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3008264082Brooklyn, NY4Jul 25, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.