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510(k) K863073

TOTAL LIPIDS by J. D. Assoc. — Product Code CFD

K863073 is an FDA 510(k) premarket notification submitted by J. D. Assoc. for the device "TOTAL LIPIDS". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code CFD (Sulfophosphovanillin, Colorimetry, Total Lipids), a Class I device regulated under 21 CFR 862.1470. J. D. Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sulfophosphovanillin, Colorimetry, Total Lipids
Device Class
Class I
Regulation Number
862.1470
Review Panel
CH
Submission Type

Other clearances by J. D. Assoc.

  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863103 — PEG 6,000 (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863109 — FERROFAST (November 24, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)

Other clearances for product code CFD

  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K813469 — LIPID PROFILE (December 31, 1981)

FDA data resources