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510(k) K052617

FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, by Good Biotech Corp. — Product Code DBF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 23, 2006
Date Received: September 23, 2005
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

Other clearances by Good Biotech Corp.

K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
K050713 — DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALO (June 6, 2005)
K050576 — MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (April 21, 2005)
K022725 — CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (September 23, 2002)
K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET (July 29, 2002)
K021882 — CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 (July 11, 2002)
K020603 — CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (June 13, 2002)

Other clearances for product code DBF

K193650 — LIAISON Ferritin (September 14, 2021)
K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Fact (March 6, 2020)
K171642 — Atellica IM Ferritin Assay (August 31, 2017)
K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTRO (June 24, 2014)
K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (May 24, 2012)
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)