The following data is part of a premarket notification filed by Amarel Precision Instruments, Inc. with the FDA for 2xc Microscope.
| Device ID | K822207 |
| 510k Number | K822207 |
| Device Name: | 2XC MICROSCOPE |
| Classification | Light, Microscope |
| Applicant | AMAREL PRECISION INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IBJ |
| CFR Regulation Number | 864.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-08-05 |