The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for G6pdh, Glucose-6-phoshate Dehydrogenase.
| Device ID | K024006 |
| 510k Number | K024006 |
| Device Name: | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | JBF |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015679 | K024006 | 000 |
| 00811727014139 | K024006 | 000 |