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Easy-Test Emit(R) Amikacin (Amik) No. 16645

by Em Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K873426

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873426 Date29 Oct 1987ClearedStatusActive

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  • Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KLP
Device Class
Class II
Regulation
21 CFR Part 862.3035
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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