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Flow Cytometry Fitc/Pe Compensation Kit

by Sigma Diagnostics, Inc. 510(k)

Active United States

510(k) K910255

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910255 Date3 Apr 1991ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIW
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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