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Enzy-Well Syphilis Igg, Model 91106

by Diesse Diagnostica Senese S.P.A Italy 510(k)

510(k) K050590 Product code LIP

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050590 Date10 Aug 2006ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LIP
FDA applicant
Diesse Diagnostica Senese S.P.A.
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K050590 24 fields · synced 22 Oct 2026