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510(k) K132828

ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 by Roche Diagnostics — Product Code JKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2013
Date Received
September 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Calcitonin
Device Class
Class II
Regulation Number
862.1140
Review Panel
CH
Submission Type

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Other clearances for product code JKR

  • K182012 — ADVIA Centaur Calcitonin (CALCT) assay (December 21, 2018)
  • K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (August 30, 2006)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K990073 — CALCITONIN (May 11, 1999)
  • K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (September 3, 1998)
  • K964635 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (May 21, 1997)
  • K961043 — SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (May 6, 1996)
  • K945961 — CALCITONIN IMMUNOASSAY KIT (November 20, 1995)
  • K951708 — ELSA-HCT (September 5, 1995)
  • K914429 — DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (January 15, 1992)