FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIDEL ALLERGY SCREEN
K Number: K861171
·
Decision Apr 25, 1986
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
93
Review Days
28
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Basic Information
- Device Name
- QUIDEL ALLERGY SCREEN
- K Number
- K861171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- March 28, 1986
- Decision Date
- April 25, 1986
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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|---|---|---|---|
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| K131166 | SOFIA(R) HCG FIA | Aug 2, 2013 | Substantially Equivalent |
| K131606 | SOFIA INFLUENZA A+B FIA | Jul 5, 2013 | Substantially Equivalent |
| K131619 | QUICKVUE INFLUENZA A+B | Jun 28, 2013 | Substantially Equivalent |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent |