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510(k) K840038

PREPAX DILUKIT PLUS by Scientific Distributors, Inc. — Product Code GIF

K840038 is an FDA 510(k) premarket notification submitted by Scientific Distributors, Inc. for the device "PREPAX DILUKIT PLUS". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Scientific Distributors, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
January 5, 1984
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 Scientific Distributors, Inc.

  • K892658 — SDI PREPAX COUNTAPETTE KIT (May 24, 1989)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K840044 — SDI PREPAX DILUKIT 29-1000 (March 9, 1984)
  • K840041 — SDI PREPAX DILUKIT HW (March 5, 1984)
  • K840042 — SDI PREPAX DILUKIT CA (February 10, 1984)
  • K840043 — SDI PREPAX DILUKIT CT (February 10, 1984)

Other clearances for product code GIF

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (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)
  • 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)

FDA data resources