The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Accudex Reagent Strips.
Device ID | K821247 |
510k Number | K821247 |
Device Name: | ACCUDEX REAGENT STRIPS |
Classification | Glucose Oxidase, Glucose |
Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-29 |
Decision Date | 1982-05-21 |