The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Glucose (hk) Reagent Strip Test.
| Device ID | K912251 |
| 510k Number | K912251 |
| Device Name: | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST |
| Classification | Hexokinase, Glucose |
| Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Contact | Frances K Loh |
| Correspondent | Frances K Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-07-18 |