Active Lh Irma

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K961109 ↗

FDA Product Code

CEP

Device Class

Class I

Regulation

21 CFR Part 862.1485

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Dsl Active Shbg (Dsl 7400)

  Class I

  FDA 510(k) K915823 Active Cleared 17 Mar 1992

• Active T3 Ria

  Class II

  FDA 510(k) K960550 Active Cleared 6 Mar 1996

• Dsl Beta 2 Microglobulin (Dsl 6200)

  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

  Class I

  FDA 510(k) K960171 Active Cleared 28 Mar 1996

• Dsl Aactive Dhea Eia Kit

  Class I

  FDA 510(k) K955114 Active Cleared 23 Feb 1996

• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

See all devices from Diagnostic Systems Laboratories, Inc. →