Modification to Copalis CMV Total Antibody Assay
FDA 510(k) K982027 · DiaSorin, Inc.
510(k) numberK982027
Submission
- Device name
- Modification to Copalis CMV Total Antibody Assay
- Applicant
- DiaSorin, Inc.
Columbia, MD, US - Received
- June 2, 1998
- Decision date
- November 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Modification to Copalis CMV Total Antibody Assay cleared by the FDA?
Modification to Copalis CMV Total Antibody Assay (K982027) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 176 days after the submission was received.
What is the product code of K982027?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.