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Gryphus Diagnostics, LLC

FDA Regulatory Profile

Gryphus Diagnostics, LLC has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 16, 2025 · VAI
Latest 510(k)
Apr 6, 2005

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 16, 2025Knoxville, TNFood/CosmeticsVoluntary Action Indicated (VAI)3006546675

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 3006546675Knoxville, TN1Jun 16, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K050755MODIFICATION TO BVBLUEApr 6, 2005
K993732BVBLUEMay 15, 2000

FDA data resources

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