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510(k) K992517

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

K992517 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "BIOCHECK FERRITIN ELISA MODEL BC-1025". The FDA issued a decision of Substantially Equivalent on September 24, 1999. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Biocheck, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Biocheck, Inc.

  • K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (December 17, 2004)
  • K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (June 16, 2004)
  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (January 8, 2002)
  • K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL (July 20, 2001)
  • K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (October 2, 2000)
  • K001022 — BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (September 26, 2000)
  • K992528 — BIOCHECK IGE ELISA, MODEL BC-1035 (September 21, 1999)
  • K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (July 22, 1999)
  • K991146 — TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (June 22, 1999)

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)

FDA data resources