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510(k) K813469

LIPID PROFILE by Bio-Analytics Laboratories, Inc. — Product Code CFD

K813469 is an FDA 510(k) premarket notification submitted by Bio-Analytics Laboratories, Inc. for the device "LIPID PROFILE". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code CFD (Sulfophosphovanillin, Colorimetry, Total Lipids), a Class I device regulated under 21 CFR 862.1470. Bio-Analytics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 11, 1981
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 Bio-Analytics Laboratories, Inc.

  • K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT (May 29, 1986)
  • K860245 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 14, 1986)
  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 1982)

Other clearances for product code CFD

  • K863073 — TOTAL LIPIDS (September 9, 1986)
  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)

FDA data resources