AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
FDA 510(k) K153150 · Inova Diagnostics, Inc.
Submission
- Device name
- AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- November 2, 2015
- Decision date
- November 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIV – Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4750
- Specialty
- Immunology
Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.
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Questions and answers
When was AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 cleared by the FDA?
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150) received a 510(k) decision of Substantially Equivalent on November 24, 2015, 22 days after the submission was received.
What is the product code of K153150?
The FDA product code is PIV – Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use, a Class II (moderate risk) device regulated under 21 CFR 866.4750.