The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Glucose-hk Reagent.
| Device ID | K873835 |
| 510k Number | K873835 |
| Device Name: | GLUCOSE-HK REAGENT |
| Classification | Hexokinase, Glucose |
| Applicant | INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview, WA 98632 |
| Contact | Lester B Garrison |
| Correspondent | Lester B Garrison INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview, WA 98632 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-21 |
| Decision Date | 1987-11-24 |