FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
WOUNDCHEK Bacterial Status
K Number: DEN180014
·
Decision Dec 2, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
17
Review Days
619
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Basic Information
- Device Name
- WOUNDCHEK Bacterial Status
- K Number
- DEN180014
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3231
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Alere Scarborough, Inc.
- Date Received
- March 23, 2018
- Decision Date
- December 2, 2019
- Product Code
- QFA
- 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 |
|---|---|---|---|
| QFA | Assay For Detection Of Proteases In Chronic Wounds | FDA class 2 | Microbiology |
Other Clearances by Alere Scarborough, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190204 | ID NOW Influenza A & B 2 | Mar 18, 2019 | Substantially Equivalent |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Aug 8, 2018 | Substantially Equivalent |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | May 2, 2018 | Substantially Equivalent |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Jan 26, 2018 | Substantially Equivalent |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Dec 13, 2017 | Substantially Equivalent |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Sep 29, 2017 | Substantially Equivalent |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Apr 10, 2017 | Substantially Equivalent |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Dec 21, 2016 | Substantially Equivalent |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Aug 18, 2016 | Substantially Equivalent |
| K161364 | BinaxNOW G6PD Test | Jun 17, 2016 | Substantially Equivalent |