Nova Lite(Tm) Ana MK
FDA 510(k) K901595 · Inova Diagnostics, Inc.
510(k) numberK901595
Submission
- Device name
- Nova Lite(Tm) Ana MK
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- April 5, 1990
- Decision date
- April 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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Questions and answers
When was Nova Lite(Tm) Ana MK cleared by the FDA?
Nova Lite(Tm) Ana MK (K901595) received a 510(k) decision of Substantially Equivalent on April 26, 1990, 21 days after the submission was received.
What is the product code of K901595?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.