The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Modification To Liquid Glucose (hexokinase) Reagent Set.
| Device ID | K002199 |
| 510k Number | K002199 |
| Device Name: | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2000-11-20 |