FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RPS ADENO DETECTOR PLUS
K Number: K110722
·
Decision May 17, 2011
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
10
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- RPS ADENO DETECTOR PLUS
- K Number
- K110722
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3020
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rapid Pathogen Screening, Inc.
- Date Received
- March 15, 2011
- Decision Date
- May 17, 2011
- Product Code
- GOD
- 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 |
|---|---|---|---|
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | FDA class 1 | Microbiology |
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Other Clearances by Rapid Pathogen Screening, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132066 | INFLAMMA DRY | Nov 21, 2013 | Substantially Equivalent |