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510(k) K892658

SDI PREPAX COUNTAPETTE KIT by Scientific Distributors, Inc. — Product Code JCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Diluting, Manual Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

Other clearances by Scientific Distributors, Inc.

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  • K840041 — SDI PREPAX DILUKIT HW (March 5, 1984)
  • K840043 — SDI PREPAX DILUKIT CT (February 10, 1984)
  • K840038 — PREPAX DILUKIT PLUS (February 10, 1984)
  • K840042 — SDI PREPAX DILUKIT CA (February 10, 1984)