510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060564Substantially Equivalent

Infiniti System

AutoGenomics, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060564 is the FDA 510(k) clearance record for INFINITI SYSTEM, a class II device, cleared for AutoGenomics, Inc. on under FDA product code NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr). FDA's definition for product code NPQ reads: "In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia". FDA records list one 510(k) clearance for AutoGenomics, Inc. As of , FDA records show no recalls naming K060564.

Clearance record

Decision date
Received
(341 days to decision)
Product code
NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Applicant
AutoGenomics, Inc. 2251 Rutherford Rd., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPQ

Trailing 12 months

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

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