510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102314Substantially Equivalent

3M Integrated Cycler (110V) & (220V)

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102314 is the FDA 510(k) clearance record for 3M INTEGRATED CYCLER (110V) & (220V), a class II device, cleared for Focus Diagnostics, Inc. on under FDA product code OOI (Real Time Nucleic Acid Amplification System). FDA's definition for product code OOI reads: "The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or...". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show no recalls naming K102314.

Clearance record

Decision date
Received
(74 days to decision)
Product code
OOI Real Time Nucleic Acid Amplification System
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Focus Diagnostics, Inc. 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOI

Trailing 12 months

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

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