The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Beta Scan Normal Control Solution.
| Device ID | K831523 |
| 510k Number | K831523 |
| Device Name: | BETA SCAN NORMAL CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ORANGE MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-07-19 |