FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K Number: K983465
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
22
Applicant Total
135
Review Days
48
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Basic Information
- Device Name
- THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K Number
- K983465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- October 1, 1998
- Decision Date
- November 18, 1998
- Product Code
- LKO
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LKO | Anti-Rnp Antibody, Antigen And Control | FDA class 2 | Immunology |
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