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510(k) K771101

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

K771101 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "HEMOGLOBIN ANALYZER & PERFORM. CHECK SET". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code GIG (Hemoglobinometer), a Class II device regulated under 21 CFR 864.7500. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

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

Other clearances by The Dow Chemical Co.

  • K823474 — ENZYMATIC GLUCOSE DETERMINATION (December 30, 1982)
  • K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION (August 5, 1982)
  • K821536 — DOWFLOW ALT-UV DETERMINATION (June 14, 1982)
  • 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)

FDA data resources