The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Glucose Liquid Amresco #4628300 & 4628001l.
| Device ID | K884909 |
| 510k Number | K884909 |
| Device Name: | GLUCOSE LIQUID AMRESCO #4628300 & 4628001L |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Dianne Eich |
| Correspondent | Dianne Eich AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-23 |
| Decision Date | 1989-01-03 |