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Infiniti System

by Autogenomics, Inc

510(k) K060564

Infiniti System is a Class II device made by Autogenomics, Inc, cleared under FDA 510(k) K060564 on 7 Feb 2007, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060564 Date7 Feb 2007ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NPQ
FDA applicant
AutoGenomics, Inc.
Device class
Class II
Regulation
21 CFR Part 864.7280
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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