510(k) K161364
- Device
- BinaxNOW G6PD Test
- Applicant
- ALERE SCARBOROUGH, INC.
- 510(k) number
- K161364
- Product code
- JBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-17
- Date received
- 2016-05-17
- Regulation
- 864.7360
- Classification name
- Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Angela Drysdale
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 1221359
- 3017662853
- 9681576
- 3011240982
- 1827821
- 3024756665
Source Documents#
Other 510(k) Records For Product Code JBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201049 | FINDER G6PD | Baebies, Inc. | 2022-09-14 |
| K080003 | BINAXNOW G6PD TEST | Binax, Inc. | 2008-10-23 |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | 2003-03-31 |
| K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | Sigma Diagnostics, Inc. | 1995-06-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary