Axsym CMV Igg Antibody Assay
FDA 510(k) K953943 · Abbott Laboratories
510(k) numberK953943
Submission
- Device name
- Axsym CMV Igg Antibody Assay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 21, 1995
- Decision date
- September 20, 1996
- 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 Axsym CMV Igg Antibody Assay cleared by the FDA?
Axsym CMV Igg Antibody Assay (K953943) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 396 days after the submission was received.
What is the product code of K953943?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.