Quanta Lite Omp Plus Elisa

FDA 510(k) K081248 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK081248

Submission

Device name
Quanta Lite Omp Plus Elisa
Applicant
Inova Diagnostics, Inc.
San Diego, CA, US
Received
May 2, 2008
Decision date
October 27, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
OKM – Antibodies, Outer-Membrane Proteins
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5785
Specialty
Immunology

For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.

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Questions and answers

When was Quanta Lite Omp Plus Elisa cleared by the FDA?

Quanta Lite Omp Plus Elisa (K081248) received a 510(k) decision of Substantially Equivalent on October 27, 2008, 178 days after the submission was received.

What is the product code of K081248?

The FDA product code is OKM – Antibodies, Outer-Membrane Proteins, a Class II (moderate risk) device regulated under 21 CFR 866.5785.