The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Glucose, Hexokinase (r1), Model Gl101-01, Glucose Hexokinase (r2), Model Gl101-02.
| Device ID | K990981 |
| 510k Number | K990981 |
| Device Name: | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 |
| Classification | Hexokinase, Glucose |
| Applicant | A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 1999-05-25 |