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Combi Scan 500 Urine Test Strip Analyzer, Model A93005

by Analyticon Biotechnologies AG 510(k)

Active United States

510(k) K061812

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061812 Date6 Apr 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIL
Device Class
Class II
Regulation
21 CFR Part 862.1340
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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