The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Beta Scan Drystix.
Device ID | K841369 |
510k Number | K841369 |
Device Name: | BETA SCAN DRYSTIX |
Classification | Glucose Oxidase, Glucose |
Applicant | ORANGE MEDICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-03 |
Decision Date | 1984-08-23 |