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510(k) K823829

FERRITIN IMMUNORADIOMETRIC ASSAY KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DFB

K823829 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "FERRITIN IMMUNORADIOMETRIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 11, 1983. The device falls under product code DFB (Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1983
Date Received
December 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5130
Review Panel
IM
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

FDA data resources