FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIDEL ALLERGY SCREEN
K Number: K883666
·
Decision Oct 18, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
261
Applicant Total
93
Review Days
53
Basic Information
- Device Name
- QUIDEL ALLERGY SCREEN
- K Number
- K883666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- QUIDEL CORP.
- Date Received
- August 26, 1988
- Decision Date
- October 18, 1988
- Product Code
- DHB
- 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 |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | FDA class 2 | Immunology |
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| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
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