FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
K Number: K821097
·
Decision May 5, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
48
Review Days
15
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Basic Information
- Device Name
- SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
- K Number
- K821097
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- April 20, 1982
- Decision Date
- May 5, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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| K821374 | ENZYMUNE-TEST INSULIN | May 28, 1982 | Substantially Equivalent |