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510(k) K771101

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET by The Dow Chemical Co. — Product Code GIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
June 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobinometer
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

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  • K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM (May 24, 1982)
  • K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS (April 1, 1982)
  • K820714 — DOW BILIRUBIN(DIRECT) DETERMINATION (April 1, 1982)
  • K812777 — DIRECT IRON REAGENT SET (October 19, 1981)
  • K811806 — QUICK-CHEM COLORIMETER (July 15, 1981)
  • K810861 — CREATINE KINASE MB ISOENZYME IMMUNO UV (April 14, 1981)
  • K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION (March 31, 1981)

Other clearances for product code GIG

  • K973995 — RANDOX BILIRUBIN (December 8, 1997)
  • K933836 — HBM HEMOGLOBINOMETER (March 31, 1994)