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510(k) K833443

ISOTONIC BLOOD CELL DILUENT J & S by Jasins & Sayles Associates, Inc. — Product Code GIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
October 5, 1983
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

Other clearances by Jasins & Sayles Associates, Inc.

  • K833444 — LYSING & HEMOGLOBIN S-REAGENT J & S (November 3, 1983)

Other clearances for product code GIF

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  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)