Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay
FDA 510(k) K951851 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK951851
Submission
- Device name
- Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Newark, DE, US - Received
- April 21, 1995
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJO – Antigen, Iha, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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Questions and answers
When was Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay cleared by the FDA?
Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay (K951851) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 460 days after the submission was received.
What is the product code of K951851?
The FDA product code is LJO – Antigen, Iha, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.