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510(k) K896922

RAICHEM TM HEMOGLOBIN REAGENT by Reagents Applications, Inc. — Product Code GKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1990
Date Received
December 11, 1989
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

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Other clearances for product code GKK

  • K894951 — MODIFIED HEMOGLOBIN REAGENT SET (October 24, 1989)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)
  • 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)