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510(k) K782110

RIA KIT, RIANEN CORTISOL by New England Nuclear — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 19, 1978
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 New England Nuclear

  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (March 30, 1984)
  • K834038 — RIANEN FOLLICLE STIMULATING HORMONE (January 30, 1984)
  • K833376 — RIANEN LUTEINIZING HORMONE RIA KIT (December 20, 1983)
  • K831345 — RIANEN PROLACTIN 125I KIT (June 8, 1983)
  • K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (June 20, 1980)
  • K792175 — RIANEN, VITAMIN B12 ASSAY SYSTEM (November 13, 1979)
  • K790817 — RIA KIT, QUANTITATION OF PROSTATIC ACID (May 7, 1979)
  • K781888 — ASSAY SYSTEM, FERRITIN I KIT (January 10, 1979)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)

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)