The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Glucose-super Fast 4983050 And 4983500.
| Device ID | K882262 |
| 510k Number | K882262 |
| Device Name: | GLUCOSE-SUPER FAST 4983050 AND 4983500 |
| 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 | 1988-05-31 |
| Decision Date | 1989-02-02 |