Binaxnow G6PD Test
FDA 510(k) K080003 · Binax, Inc.
510(k) numberK080003
Submission
- Device name
- Binaxnow G6PD Test
- Applicant
- Binax, Inc.
Scarborough, ME, US - Received
- January 2, 2008
- Decision date
- October 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K161364 | BinaxNOW G6PD TestJBF · Special | Alere Scarborough, Inc. | 06/17/2016SE |
| 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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| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
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| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
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Questions and answers
When was Binaxnow G6PD Test cleared by the FDA?
Binaxnow G6PD Test (K080003) received a 510(k) decision of Substantially Equivalent on October 23, 2008, 295 days after the submission was received.
What is the product code of K080003?
The FDA product code is JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a Class II (moderate risk) device regulated under 21 CFR 864.7360.