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510(k) K161951

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay by Kronus, Inc. — Product Code PNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2016
Date Received
July 15, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aquaporin-4 Autoantibody
Device Class
Class II
Regulation Number
866.5665
Review Panel
IM
Submission Type

For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings.

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  • K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (July 25, 1989)
  • K894203 — ANTI-THYROGLOBULIN TEST KIT (July 25, 1989)

Other clearances for product code PNI

  • DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (April 25, 2016)