FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI DS-DNA
K Number: K943291
·
Decision Dec 2, 1994
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
164
Review Days
147
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Basic Information
- Device Name
- ANTI DS-DNA
- K Number
- K943291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sigma Diagnostics, Inc.
- Date Received
- July 8, 1994
- Decision Date
- December 2, 1994
- 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 Sigma Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | Aug 30, 2002 | Substantially Equivalent |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Feb 6, 2002 | Substantially Equivalent |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Dec 26, 2001 | Substantially Equivalent |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Nov 15, 2001 | Substantially Equivalent |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Nov 15, 2001 | Substantially Equivalent |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Oct 26, 2001 | Substantially Equivalent |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Mar 30, 2001 | Substantially Equivalent |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Mar 22, 2001 | Substantially Equivalent |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Mar 15, 2001 | Substantially Equivalent |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Mar 1, 2001 | Substantially Equivalent |