510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080125Substantially Equivalent

Apolowako T-Cho, Hdl-C, Tg and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201

FUJIFILM Healthcare Americas Corporation, Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080125 is the FDA 510(k) clearance record for APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K080125.

Clearance record

Decision date
Received
(183 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
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
510(k) summary
Summary PDF
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