G6PDH, GLUCOSE-6-PHOSHATE Dehydrogenase
FDA 510(k) K024006 · Pointe Scientific, Inc.,
510(k) numberK024006
Submission
- Device name
- G6PDH, GLUCOSE-6-PHOSHATE Dehydrogenase
- Applicant
- Pointe Scientific, Inc.,
Lincoln Park, MI, US - Received
- December 4, 2002
- Decision date
- March 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K080003 | Binaxnow G6PD TestJBF · Traditional | Binax, Inc. | 10/23/2008SE |
| K933934 | GLUCOSE-6-PHOSPHATE Dehydrogenase Deficiency Screening Test Kit No. 202-AJBF · Traditional | Sigma Diagnostics, Inc. | 06/29/1995SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | 12/04/2007SE |
| K062118 | Pointe 360CFR · Traditional | 07/13/2007SE |
| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | 04/30/2007SE |
| K070207 | Multi-Analyte Chemistry CalibratorJIX · Abbreviated | 04/13/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | 04/11/2007SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | 03/28/2007SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | 10/07/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | 06/02/2004SE |
| K031539 | Hemoglobin A1C Reagent SetLCP · Traditional | 08/06/2003SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | 04/28/2003SE |
Questions and answers
When was G6PDH, GLUCOSE-6-PHOSHATE Dehydrogenase cleared by the FDA?
G6PDH, GLUCOSE-6-PHOSHATE Dehydrogenase (K024006) received a 510(k) decision of Substantially Equivalent on March 31, 2003, 117 days after the submission was received.
What is the product code of K024006?
The FDA product code is JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a Class II (moderate risk) device regulated under 21 CFR 864.7360.