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510(k) K760123

AUTOZYME by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KSK

K760123 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "AUTOZYME". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code KSK (Solution, Stabilized Enzyme), a Class II device regulated under 21 CFR 864.9400. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 28, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Stabilized Enzyme
Device Class
Class II
Regulation Number
864.9400
Review Panel
HE
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 KSK

  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 1982)
  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)

FDA data resources