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510(k) K860112

TOTAL LIPIDS REAGENT SET by Technostics Intl. — Product Code CFD

K860112 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "TOTAL LIPIDS REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code CFD (Sulfophosphovanillin, Colorimetry, Total Lipids), a Class I device regulated under 21 CFR 862.1470. Technostics Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
January 13, 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 Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860109 — ENZYMATIC UREA NITROGEN REAGENT SET (February 6, 1986)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET (January 21, 1986)
  • K855195 — DIRECT & TOTAL BILIRUBIN SET (January 14, 1986)
  • K855191 — TOTAL PROTEIN REAGENT SET (January 14, 1986)
  • K855154 — INORGANIC PHOSPHORUS REAGENT SET (January 14, 1986)

Other clearances for product code CFD

  • K863073 — TOTAL LIPIDS (September 9, 1986)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K813469 — LIPID PROFILE (December 31, 1981)

FDA data resources