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510(k) K894578

IQ LDH by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CFH

K894578 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "IQ LDH". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. 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 17, 1989
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
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 CFH

  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)
  • K020484 — CARESIDE LDH (July 3, 2002)
  • K895138 — CLINISTAT LDH REAGENT TEST (October 19, 1989)
  • K880630 — LACTATE DEHYDROGENASE (LDH-L) (March 16, 1988)
  • K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (February 28, 1986)
  • K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (October 1, 1985)
  • K842452 — WAKO LDH CII TEST (August 15, 1984)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K812836 — LDH REAGENT SET (October 9, 1981)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)

FDA data resources