The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hichem Glucose/hk Reagent Kit.
| Device ID | K960084 |
| 510k Number | K960084 |
| Device Name: | HICHEM GLUCOSE/HK REAGENT KIT |
| Classification | Hexokinase, Glucose |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HI CHEM, INC. 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-04-04 |
| Summary: | summary |