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510(k) K851320

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

K851320 is an FDA 510(k) premarket notification submitted by Scientific Distributors, Inc. for the device "SDI PREPAX DILUKIT M.". The FDA issued a decision of Substantially Equivalent on July 5, 1985. 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
July 5, 1985
Date Received
April 2, 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

Other clearances by Scientific Distributors, Inc.

  • K892658 — SDI PREPAX COUNTAPETTE KIT (May 24, 1989)
  • 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)
  • K840038 — PREPAX DILUKIT PLUS (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)
  • K851280 — DASS PACK (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources