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510(k) K894951

MODIFIED HEMOGLOBIN REAGENT SET by Macomb Biotechnology, Inc. — Product Code GKK

K894951 is an FDA 510(k) premarket notification submitted by Macomb Biotechnology, Inc. for the device "MODIFIED HEMOGLOBIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. Macomb Biotechnology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 20, 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

Other clearances by Macomb Biotechnology, Inc.

  • K871902 — THE URIC ACID REAGENT SET (June 3, 1987)

Other clearances for product code GKK

  • K896922 — RAICHEM TM HEMOGLOBIN REAGENT (January 25, 1990)
  • 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)

FDA data resources