BinaxNOW G6PD Test
FDA 510(k) K161364 · Alere Scarborough, Inc.
510(k) numberK161364
Submission
- Device name
- BinaxNOW G6PD Test
- Applicant
- Alere Scarborough, Inc.
Scarborough, ME, US - Received
- May 17, 2016
- Decision date
- June 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7360
- Specialty
- Hematology
Other 510(k)s with product code JBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201049 | Finder G6PDJBF · Traditional | Baebies, Inc. | 09/14/2022SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | Binax, Inc. | 10/23/2008SE |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DehydrogenaseJBF · Traditional | Pointe Scientific, Inc., | 03/31/2003SE |
| K933934 | GLUCOSE-6-PHOSPHATE Dehydrogenase Deficiency Screening Test Kit No. 202-AJBF · Traditional | Sigma Diagnostics, Inc. | 06/29/1995SE |
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| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…PSZ · Special | 12/13/2017SE |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC · Traditional | 09/29/2017SE |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…PSZ · Traditional | 04/10/2017SE |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentOCC · Special | 12/21/2016SE |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC · Traditional | 08/18/2016SE |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC · Traditional | 07/28/2015SE |
Questions and answers
When was BinaxNOW G6PD Test cleared by the FDA?
BinaxNOW G6PD Test (K161364) received a 510(k) decision of Substantially Equivalent on June 17, 2016, 31 days after the submission was received.
What is the product code of K161364?
The FDA product code is JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a Class II (moderate risk) device regulated under 21 CFR 864.7360.