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510(k) K760123

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

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

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  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
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  • 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)