510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813469Substantially Equivalent

Lipid Profile

Bio-Analytics Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813469 is the FDA 510(k) clearance record for LIPID PROFILE, a class I device, cleared for Bio-Analytics Laboratories, Inc. on under FDA product code CFD (Sulfophosphovanillin, Colorimetry, Total Lipids). FDA records list 19 510(k) clearances for Bio-Analytics Laboratories, Inc., from to . As of , FDA records show no recalls naming K813469.

Clearance record

Decision date
Received
(20 days to decision)
Product code
CFD Sulfophosphovanillin, Colorimetry, Total Lipids
Regulation
21 CFR 862.1470
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio-Analytics Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CFD

Trailing 12 months

FDA records hold no clearances under product code CFD in the trailing twelve months.

FDA records show no clearances under product code CFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260