FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IS-DSDNA TEST SYSTEM
K Number: K974694
·
Decision Mar 3, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
68
Review Days
77
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Basic Information
- Device Name
- IS-DSDNA TEST SYSTEM
- K Number
- K974694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diamedix Corp.
- Date Received
- December 16, 1997
- Decision Date
- March 3, 1998
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRM), ordered by most recent decision date.
IMMULISA DSDNA ANTIBODY ELISA
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EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
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FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
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VARELISA SSDNA ANTIBODIES, MODEL 14896
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FDA Class 2
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ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
MDI DS-DNA TEST
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Diamedix Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K093101 | MAGO 4S | Jan 21, 2011 | Substantially Equivalent |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Jan 8, 2002 | Substantially Equivalent |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Dec 21, 2001 | Substantially Equivalent |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | Oct 26, 2001 | Substantially Equivalent |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | Oct 26, 2001 | Substantially Equivalent |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | Aug 20, 2001 | Substantially Equivalent |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | Nov 28, 2000 | Substantially Equivalent |