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 |