FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPS IGG TEST
K Number: K961204
·
Decision Jul 18, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
135
Review Days
113
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Basic Information
- Device Name
- MUMPS IGG TEST
- K Number
- K961204
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- March 27, 1996
- Decision Date
- July 18, 1996
- Product Code
- LJY
- 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 |
|---|---|---|---|
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJY), ordered by most recent decision date.
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VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
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PHARMACIA MUMPS IGG ELISA
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