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510(k) K873347

CELL-DYN DIFF. SCREEN ISOTONIC DILUENT by Abbott Diagnostics — Product Code GIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
August 20, 1987
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 Abbott Diagnostics

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  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)
  • K870233 — CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (March 17, 1987)

Other clearances for product code GIF

  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (July 25, 1988)
  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • 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)
  • K850095 — LASER-DIL (March 29, 1985)