510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191030Substantially Equivalent

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

Life Technologies Corporation, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191030 is the FDA 510(k) clearance record for Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer, a class II device, cleared for Life Technologies Corporation on under FDA product code PCA (Dna Genetic Analyzer). FDA's definition for product code PCA reads: "A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual...". FDA records list 11 510(k) clearances for Life Technologies Corporation, from to . As of , FDA records show no recalls naming K191030.

Clearance record

Decision date
Received
(309 days to decision)
Product code
PCA Dna Genetic Analyzer
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Life Technologies Corporation 5781 Van Allen Way, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCA

Trailing 12 months

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

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