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510(k) K781303

BIO-PRO UNIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FKR

K781303 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BIO-PRO UNIT". The FDA issued a decision of Substantially Equivalent on October 2, 1978. The device falls under product code FKR (Subsystem, Proportioning), a Class II device regulated under 21 CFR 876.5820. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1978
Date Received
July 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)

Other clearances for product code FKR

  • K140571 — NXSTAGE PUREFLOW SL (May 15, 2014)
  • K111174 — NXSTAGE PUREFLOW SL (September 19, 2011)
  • K080919 — NXSTAGE PUREFLOW SL (October 15, 2008)
  • K060296 — NXSTAGE DIALYSATE PREPARATION MODULE (March 31, 2006)
  • K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (March 17, 2005)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 1985)
  • K850756 — AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (March 20, 1985)
  • K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEM (June 16, 1981)
  • K810127 — GAMBRO BICARBONATE MODULE, BCM-10 (February 25, 1981)
  • K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (November 12, 1980)

FDA data resources