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510(k) K863901

IQ UREA NITROGEN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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  • 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)

Other clearances for product code JGZ

  • K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (October 12, 1990)
  • K896236 — COBAS READY BUN REAGENT (February 27, 1990)
  • K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (January 23, 1989)
  • K842772 — PHARMACIA B2-MICRO RIA (November 1, 1984)
  • K840213 — BLOOD UREA NITROGEN REAGENT SYS (March 19, 1984)
  • K820418 — K.D. COLORIMETRIC BLOOD UREA N2 TEST (March 11, 1982)
  • K810087 — UREA NITROGEN, KINETIC (February 26, 1981)
  • K801269 — SERALYZER BLOOD UREA NITROGEN(BUN) (July 8, 1980)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K770504 — REAGENT SYSTEM (June 27, 1977)