The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Glucose-hexokinase Reagents 4470030,050,300,600.
| Device ID | K896028 |
| 510k Number | K896028 |
| Device Name: | GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 |
| Classification | Hexokinase, Glucose |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | C. K Owens |
| Correspondent | C. K Owens AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1989-11-14 |