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510(k) K943427

ACE CEDIA CORTISOL ASSAY by Schiapparelli Biosystems, Inc. — Product Code CGR

K943427 is an FDA 510(k) premarket notification submitted by Schiapparelli Biosystems, Inc. for the device "ACE CEDIA CORTISOL ASSAY". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Schiapparelli Biosystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
July 15, 1994
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 Schiapparelli Biosystems, Inc.

  • K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (July 13, 1999)
  • K981377 — ACE T4 REAGENT T4 CALIBRATORS (June 10, 1998)
  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K973536 — ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (November 6, 1997)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (October 20, 1997)
  • K971526 — ACE HDL-C REAGENT (May 21, 1997)

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