Quanta Lite Ss-A 52 Elisa

FDA 510(k) K063565 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK063565

Submission

Device name
Quanta Lite Ss-A 52 Elisa
Applicant
Inova Diagnostics, Inc.
San Diego, CA, US
Received
November 28, 2006
Decision date
April 4, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
OBE – Anti-Ss-A 52 Autoantibodies
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Other 510(k)s with product code OBE

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K141655Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsOBE · Traditional Inova Diagnostics, Inc.03/05/2015SE

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Questions and answers

When was Quanta Lite Ss-A 52 Elisa cleared by the FDA?

Quanta Lite Ss-A 52 Elisa (K063565) received a 510(k) decision of Substantially Equivalent on April 4, 2007, 127 days after the submission was received.

What is the product code of K063565?

The FDA product code is OBE – Anti-Ss-A 52 Autoantibodies, a Class II (moderate risk) device regulated under 21 CFR 866.5100.