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510(k) K842068

IDI ISOTONIC DILUENT by Interscience Diagnostics, Inc. — Product Code GIF

K842068 is an FDA 510(k) premarket notification submitted by Interscience Diagnostics, Inc. for the device "IDI ISOTONIC DILUENT". The FDA issued a decision of Substantially Equivalent on July 2, 1984. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Interscience Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1984
Date Received
May 23, 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 Interscience Diagnostics, Inc.

  • K854166 — HEMATOLOGY CALIBRATOR CONTROL (March 12, 1986)
  • K842070 — IDD DETERGENT (July 2, 1984)
  • K842069 — IDL-LYSING REAGENT (July 2, 1984)

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)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)

FDA data resources