Home / 510(k) Clearances / K883992

510(k) K883992

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

K883992 is an FDA 510(k) premarket notification submitted by Kvm Technologies, Inc. for the device "KVM PREPACK HEMATOLOGY REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. 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
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)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (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)

FDA data resources