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510(k) K760009

COLORIMETRIC DETERMINATION (LDH) by The Dow Chemical Co. — Product Code CFH

K760009 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "COLORIMETRIC DETERMINATION (LDH)". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 10, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
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 CFH

  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)
  • K020484 — CARESIDE LDH (July 3, 2002)
  • K895138 — CLINISTAT LDH REAGENT TEST (October 19, 1989)
  • K894578 — IQ LDH (October 17, 1989)
  • K880630 — LACTATE DEHYDROGENASE (LDH-L) (March 16, 1988)
  • K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (February 28, 1986)
  • K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (October 1, 1985)
  • K842452 — WAKO LDH CII TEST (August 15, 1984)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K812836 — LDH REAGENT SET (October 9, 1981)

FDA data resources