510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171971Substantially Equivalent

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

Lite-On Technology Corp. H.S.P.B., Hsinchu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171971 is the FDA 510(k) clearance record for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer, a class II device, cleared for Lite-On Technology Corp. H.S.P.B. on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list one 510(k) clearance for Lite-On Technology Corp. H.S.P.B. As of , FDA records show no recalls naming K171971.

Clearance record

Decision date
Received
(209 days to decision)
Product code
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Lite-On Technology Corp. H.S.P.B. 8, Dusing Rd., Hsinchu Science Park, Hsinchu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CJE

Trailing 12 months
1 clearance under product code CJE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CJE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260