Quanta Lite CMV Igg Elisa
FDA 510(k) K971335 · Inova Diagnostics, Inc.
510(k) numberK971335
Submission
- Device name
- Quanta Lite CMV Igg Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- April 10, 1997
- Decision date
- December 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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Questions and answers
When was Quanta Lite CMV Igg Elisa cleared by the FDA?
Quanta Lite CMV Igg Elisa (K971335) received a 510(k) decision of Substantially Equivalent on December 1, 1997, 235 days after the submission was received.
What is the product code of K971335?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.