510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021671Substantially Equivalent

Jas Hdl Cholesterol (Automated) Reagent

JAS Diagnostics/Drew Scientific, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021671 is the FDA 510(k) clearance record for JAS HDL CHOLESTEROL (AUTOMATED) REAGENT, a class I device, cleared for Jas Diagnostics, Inc. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 20 510(k) clearances for JAS Diagnostics/Drew Scientific, from to . As of , FDA records show no recalls naming K021671.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Jas Diagnostics, Inc. 7220 NW 58th St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code LBS

Trailing 12 months

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

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