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510(k) K800550

LIPASE DETERMINATION by The Dow Chemical Co. — Product Code CFG

K800550 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "LIPASE DETERMINATION". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code CFG (Oil Emulsion/Thymolphthalein (Titrimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Device Class
Class I
Regulation Number
862.1465
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 CFG

  • K860554 — SERUM LIPASE REAGENT SET (TURBIDIMETRIC) (March 14, 1986)

FDA data resources