Nova Lite Endomysial
FDA 510(k) K980312 · Inova Diagnostics, Inc.
510(k) numberK980312
Submission
- Device name
- Nova Lite Endomysial
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- January 27, 1998
- Decision date
- April 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| K944191 | Anti-Nuclear Antibody(Ana) Test Kit W/Mouse LiverDBL · Traditional | Light Diagnostics | 03/06/1995SE |
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Questions and answers
When was Nova Lite Endomysial cleared by the FDA?
Nova Lite Endomysial (K980312) received a 510(k) decision of Substantially Equivalent on April 2, 1998, 65 days after the submission was received.
What is the product code of K980312?
The FDA product code is DBL – Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5660.