Quanta Lite Actin (Anti-Smooth Muscle) Elisa
FDA 510(k) K021648 · Inova Diagnostics, Inc.
510(k) numberK021648
Submission
- Device name
- Quanta Lite Actin (Anti-Smooth Muscle) Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- May 20, 2002
- Decision date
- September 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NJF – Antibodies, Anti-Actin, Anti-Smooth Muscle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5120
- Specialty
- Immunology
The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.
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Questions and answers
When was Quanta Lite Actin (Anti-Smooth Muscle) Elisa cleared by the FDA?
Quanta Lite Actin (Anti-Smooth Muscle) Elisa (K021648) received a 510(k) decision of Substantially Equivalent on September 20, 2002, 123 days after the submission was received.
What is the product code of K021648?
The FDA product code is NJF – Antibodies, Anti-Actin, Anti-Smooth Muscle, a Class II (moderate risk) device regulated under 21 CFR 866.5120.