FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSIGN FLU A + B, STATUS FLU A & B
K Number: K133474
·
Decision Dec 10, 2013
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
72
Review Days
28
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Basic Information
- Device Name
- BIOSIGN FLU A + B, STATUS FLU A & B
- K Number
- K133474
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- November 12, 2013
- Decision Date
- December 10, 2013
- Product Code
- PSZ
- 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 |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
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Other Clearances by Princeton BioMeditech Corp.
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|---|---|---|---|
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| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Sep 9, 2013 | Substantially Equivalent |
| K083746 | BIOSIGN FLU A+B | Nov 10, 2010 | Substantially Equivalent |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 1, 2010 | Substantially Equivalent |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 | Substantially Equivalent |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Oct 6, 2008 | Substantially Equivalent |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Nov 26, 2007 | Substantially Equivalent |