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510(k) K851280

DASS PACK by Dass, Inc. — Product Code GIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diluent, Blood Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

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  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)
  • K850095 — LASER-DIL (March 29, 1985)