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510(k) K862871

RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL by Cambridge Medical Technology — Product Code CGR

K862871 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
July 29, 1986
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 Cambridge Medical Technology

  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K890836 — RIA-GNOST PROGESTERONE (March 16, 1989)
  • K890697 — RIA-GNOST FERRITIN (March 16, 1989)
  • K873737 — NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (November 24, 1987)
  • K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (April 22, 1987)
  • K860130 — TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT (February 19, 1986)
  • K855169 — T3 UPTAKE RADIOIMMUNOASSAY KIT (February 6, 1986)
  • K850254 — PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (April 3, 1985)
  • K843635 — MATCHED COMPONENT SET FOR RADIOIMMUNO- (September 28, 1984)
  • K841042 — MATCHED COMPONENT SET RADIOIMMUNOASSAY (April 19, 1984)

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