FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BinaxNOW G6PD Test
K Number: K161364
·
Decision Jun 17, 2016
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
4
Applicant Total
17
Review Days
31
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Basic Information
- Device Name
- BinaxNOW G6PD Test
- K Number
- K161364
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7360
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alere Scarborough, Inc.
- Date Received
- May 17, 2016
- Decision Date
- June 17, 2016
- Product Code
- JBF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBF), ordered by most recent decision date.
FINDER G6PD
FDA 510(k)
FDA Class 2
·Hematology
BINAXNOW G6PD TEST
FDA 510(k)
FDA Class 2
·Hematology
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
FDA 510(k)
FDA Class 2
·Hematology
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Alere Scarborough, Inc.
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|---|---|---|---|
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| 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 |