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510(k) K931177

SYNELISA CORTISOL by Elias U.S.A., Inc. — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1993
Date Received
March 9, 1993
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 Elias U.S.A., Inc.

  • K964385 — ELIAS ANA-HEP-2 (March 6, 1997)
  • K963291 — VARELISA ANA (4) PROFILE (September 30, 1996)
  • K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES (August 30, 1996)
  • K953587 — VARELISA MPO-ANCA (January 26, 1996)
  • K953586 — VARELISA PR3-ANCA (January 26, 1996)
  • K951187 — VARELISA CARDIOLIPIN ABS SCREEN (October 2, 1995)
  • K951205 — VARELISA ANA PROFILE (April 17, 1995)
  • K944334 — VARELISA COMBINED DNA ANTIBODIES EIA (April 17, 1995)
  • K951206 — VARELISA PARIETAL CELL ANTIBODIES (April 17, 1995)
  • K951186 — VARELISA ANA-4 SCREEN (April 17, 1995)

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)