510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932766Substantially Equivalent

Hdl-Cholestral(dextran Sulfate/magnesium)

Diagnostic Chemicals, Ltd. (USA), Charlottestown,Pei,Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932766 is the FDA 510(k) clearance record for HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM), a class I device, cleared for Diagnostic Chemicals, Ltd. (Usa) on under FDA product code LBR (Ldl & Vldl Precipitation, Hdl). FDA records list 77 510(k) clearances for Diagnostic Chemicals, Ltd. (Usa), from to . As of , FDA records show no recalls naming K932766.

Clearance record

Decision date
Received
(185 days to decision)
Product code
LBR Ldl & Vldl Precipitation, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals, Ltd. (Usa) 16 First St., Charlottestown,Pei,Canada, CA
510(k) summary
Statement
Third party review
No

Clearances, product code LBR

Trailing 12 months

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

FDA records show no clearances under product code LBR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBR, 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