The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the
FDA 510(k) K983803 · Zeus Scientific, Inc.
510(k) numberK983803
Submission
- Device name
- The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- October 28, 1998
- Decision date
- December 14, 1998
- 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 The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the cleared by the FDA?
The Aptus (Automated) Application of the CMV Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the (K983803) received a 510(k) decision of Substantially Equivalent on December 14, 1998, 47 days after the submission was received.
What is the product code of K983803?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.