FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K Number: K150358
·
Decision Nov 12, 2015
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
14
Review Days
273
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Basic Information
- Device Name
- Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K Number
- K150358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gold Standard Diagnostics
- Date Received
- February 12, 2015
- Decision Date
- November 12, 2015
- Product Code
- GMQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMQ), ordered by most recent decision date.
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