Home / 510(k) Clearances / K992517

510(k) K992517

BIOCHECK FERRITIN ELISA MODEL BC-1025 by Biocheck, Inc. — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
July 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5340
Review Panel
IM
Submission Type

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  • K990993 — BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1 (June 22, 1999)

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  • K110736 — ADVIA CHEMISTRY FERRITIN (FRT) METHOD (August 17, 2011)
  • K100538 — TINA-QUANT FERRITIN GEN. 4 (June 22, 2010)
  • K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (December 11, 2009)
  • K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (November 20, 2006)
  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)