BINAXNOW G6PD TEST
FDA 510(k) clearance K080003 · decided 2008-10-23
Clearance details
- K-number
- K080003
- Device name
- BINAXNOW G6PD TEST
- Applicant
- Binax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-02
- Decision date
- 2008-10-23
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- JBF
- Device class
- 2
- Regulation number
- 864.7360
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FINDER G6PD (K201049) | Baebies, Inc. | 2022-09-14 |
| BinaxNOW G6PD Test (K161364) | Alere Scarborough, Inc. | 2016-06-17 |
| G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006) | Pointe Scientific, Inc., | 2003-03-31 |
| GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934) | Sigma Diagnostics, Inc. | 1995-06-29 |
Recalls involving this device
No recalls on record reference this clearance.