Home / 510(k) Clearances / K973202

510(k) K973202

MODIFICATION OF OPUS FERRITIN TEST SYSTEM by Behring Diagnostics, Inc. — Product Code DBF

K973202 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "MODIFICATION OF OPUS FERRITIN TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1997. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1997
Date Received
July 8, 1997
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 Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)

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