FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K Number: K984133
·
Decision Jan 11, 1999
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
135
Review Days
54
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Basic Information
- Device Name
- THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K Number
- K984133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- November 18, 1998
- Decision Date
- January 11, 1999
- Product Code
- LLM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | FDA class 1 | Microbiology |
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