Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay
FDA 510(k) K946353 · Mrl Diagnostics
510(k) numberK946353
Submission
- Device name
- Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- December 30, 1994
- Decision date
- July 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLM – Test, Antigen, Nuclear, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
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Questions and answers
When was Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay cleared by the FDA?
Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay (K946353) received a 510(k) decision of Substantially Equivalent on July 21, 1995, 203 days after the submission was received.
What is the product code of K946353?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.