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510(k) K883989

KVM ISOTONIC FLUSH SOLUTION by Kvm Technologies, Inc. — Product Code GIF

K883989 is an FDA 510(k) premarket notification submitted by Kvm Technologies, Inc. for the device "KVM ISOTONIC FLUSH SOLUTION". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Kvm Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
September 20, 1988
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 Kvm Technologies, Inc.

  • K925666 — THERAPACER 3000 (March 9, 1993)
  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 1988)

Other clearances for product code GIF

  • 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)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources