K822207 is an FDA 510(k) clearance for the 2XC MICROSCOPE. This device is classified as a Light, Microscope (Class I - General Controls, product code IBJ).
Submitted by Amarel Precision Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982, 13 days after receiving the submission on July 23, 1982.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3600.
| 510(k) Number | K822207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1982 |
| Decision Date | August 05, 1982 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IBJ — Light, Microscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3600 |