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510(k) K800539

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KZJ

K800539 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DISP. HYDROGEN & CO2 GENERATOR ENVELOPE". The FDA issued a decision of Substantially Equivalent on April 8, 1980. The device falls under product code KZJ (Device, Gas Generating), a Class I device regulated under 21 CFR 866.2580. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1980
Date Received
March 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
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 KZJ

  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K872782 — BBL(R) GASPAK CO2 POUCH(TM) (August 6, 1987)
  • K871709 — ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (May 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853534 — BBL CAMPY POUCH (August 29, 1985)
  • K845008 — BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (March 5, 1985)
  • K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (January 30, 1985)
  • K841117 — GASPAK PLUS DISPOS. HYDROGEN & (April 4, 1984)

FDA data resources