Home / 510(k) Clearances / K870969

510(k) K870969

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT by Canadian Bioclinical, Ltd. — Product Code CGR

K870969 is an FDA 510(k) premarket notification submitted by Canadian Bioclinical, Ltd. for the device "CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on June 22, 1987. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Canadian Bioclinical, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1987
Date Received
March 10, 1987
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 Canadian Bioclinical, Ltd.

  • K933794 — ANI BIOCARD(TM) HCG TEST (May 19, 1994)
  • K870968 — TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (June 22, 1987)
  • K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (February 2, 1987)

Other clearances for product code CGR

  • K242190 — Access Cortisol; DxC 500i Clinical Analyzer (March 5, 2025)
  • K223038 — Access Cortisol (February 8, 2023)
  • K202136 — IDS Cortisol (April 13, 2021)
  • K203270 — IMMULITE/IMMULITE® 1000 Cortisol (January 15, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (January 15, 2021)
  • K062626 — CORTISOL ELISA (December 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
  • K052359 — IBL CORTISOL LIA TEST KIT (October 3, 2005)
  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (February 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)

FDA data resources