FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENCORE ENA COMBINED EIA
K Number: K931543
·
Decision Sep 8, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
14
Review Days
163
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Basic Information
- Device Name
- ENCORE ENA COMBINED EIA
- K Number
- K931543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clark Laboratories, Inc.
- Date Received
- March 29, 1993
- Decision Date
- September 8, 1993
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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Other Clearances by Clark Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980912 | VCA IGG ELISA TEST SYSTEM | Jul 22, 1998 | Substantially Equivalent |
| K980596 | VCA IGM ELISA TEST SYSTEM | Jul 22, 1998 | Substantially Equivalent |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | May 1, 1998 | Substantially Equivalent |
| K973123 | EA-D IGG ELISA TEST SYSTEM | Mar 26, 1998 | Substantially Equivalent |
| K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA | Jan 26, 1993 | Substantially Equivalent |
| K923537 | ENCORE DS-DNA | Dec 23, 1992 | Substantially Equivalent |
| K921870 | ENCORE SM/RNP | Dec 1, 1992 | Substantially Equivalent |
| K921572 | ENCORE SM | Dec 1, 1992 | Substantially Equivalent |
| K922340 | ENCORE SS-B | Oct 16, 1992 | Substantially Equivalent |
| K922157 | ENCORE SS-A | Oct 13, 1992 | Substantially Equivalent |