FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREND PSA PLUS (REAGENT CARTRIDGE)
K Number: K124056
·
Decision May 29, 2013
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
1
Review Days
149
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Basic Information
- Device Name
- FREND PSA PLUS (REAGENT CARTRIDGE)
- K Number
- K124056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanoentek, Inc.
- Date Received
- December 31, 2012
- Decision Date
- May 29, 2013
- Product Code
- LTJ
- 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |
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