510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173127Substantially Equivalent

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

Skyla Corporation H.S.P.B, Hsinchu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173127 is the FDA 510(k) clearance record for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit), a class II device, cleared for Skyla Corporation H.S.P.B on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list one 510(k) clearance for Skyla Corporation H.S.P.B. As of , FDA records show no recalls naming K173127.

Clearance record

Decision date
Received
(361 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Skyla Corporation H.S.P.B 1f, #8, Dusing Rd., Hsinchu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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