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510(k) K771117

CENTRIA CORTISOL RIA by Clinical Diagnostics, Inc. — Product Code CGR

K771117 is an FDA 510(k) premarket notification submitted by Clinical Diagnostics, Inc. for the device "CENTRIA CORTISOL RIA". The FDA issued a decision of Substantially Equivalent on June 23, 1977. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Clinical Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1977
Date Received
June 21, 1977
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 Clinical Diagnostics, Inc.

  • K971653 — GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (January 2, 1998)
  • K951457 — GLUCOCHEK POCKETLAB (February 22, 1996)
  • K940215 — GLUCOCHEK (January 17, 1995)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)
  • K771813 — CENTRIFICHEM SYS 400 ANALYZER (October 25, 1977)
  • K771118 — CENTRIA SEPARATION COLUMNS TYPE A (July 11, 1977)
  • K761272 — CENTRIA T4 RIA (March 16, 1977)

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