G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
FDA 510(k) clearance K024006 · decided 2003-03-31
Clearance details
- K-number
- K024006
- Device name
- G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2002-12-04
- Decision date
- 2003-03-31
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- JBF
- Device class
- 2
- Regulation number
- 864.7360
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincoln Park, MI, 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 |
| BINAXNOW G6PD TEST (K080003) | Binax, Inc. | 2008-10-23 |
| GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934) | Sigma Diagnostics, Inc. | 1995-06-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Le recall (Z-2487-2015) | Pointe Scientific, Inc. | 2015-08-31 |