The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Beta Scan Trends Meter.
| Device ID | K851822 |
| 510k Number | K851822 |
| Device Name: | BETA SCAN TRENDS METER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ORANGE MEDICAL INSTRUMENTS, INC. 3183 AIRWAY AVE. SUITE F Costa Mesa, CA 92626 |
| Contact | James B Burt |
| Correspondent | James B Burt ORANGE MEDICAL INSTRUMENTS, INC. 3183 AIRWAY AVE. SUITE F Costa Mesa, CA 92626 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-10-03 |