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510(k) K883992

KVM PREPACK HEMATOLOGY REAGENT SET by Kvm Technologies, Inc. — Product Code GKK

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
Cyanomethemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Kvm Technologies, Inc.

  • K925666 — THERAPACER 3000 (March 9, 1993)
  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)

Other clearances for product code GKK

  • K896922 — RAICHEM TM HEMOGLOBIN REAGENT (January 25, 1990)
  • K894951 — MODIFIED HEMOGLOBIN REAGENT SET (October 24, 1989)
  • K821202 — HEMOGLOBIN REAGENT SET (May 24, 1982)
  • K771716 — CYMET-PLUS (September 20, 1977)
  • K771090 — UNIPAK HEMOGLOBIN (July 11, 1977)
  • K770803 — HEMOTOLOGY PRODU&TS (5 IN ALL) (July 5, 1977)