510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895381Substantially Equivalent

Hdl Singles

Trace America, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895381 is the FDA 510(k) clearance record for HDL SINGLES, a class I device, cleared for Trace America, Inc. on under FDA product code LBR (Ldl & Vldl Precipitation, Hdl). FDA records list 22 510(k) clearances for Trace America, Inc., from to . As of , FDA records show no recalls naming K895381.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LBR Ldl & Vldl Precipitation, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Trace America, Inc. 7260 NW 58th St., Miami FL
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