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510(k) K052359

IBL CORTISOL LIA TEST KIT by Lehnus & Associates Consulting — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2005
Date Received
August 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

Other clearances by Lehnus & Associates Consulting

  • K103574 — PREGNANCY ONE STEP RAPID TEST (July 28, 2011)

Other clearances for product code CGR

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  • K223038 — Access Cortisol (February 8, 2023)
  • K202136 — IDS Cortisol (April 13, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (January 15, 2021)
  • K203270 — IMMULITE/IMMULITE® 1000 Cortisol (January 15, 2021)
  • K062626 — CORTISOL ELISA (December 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (February 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K010790 — CORTISOL LIA (January 29, 2002)