K812222 is an FDA 510(k) clearance for the EM-X. This device is classified as a Media, Potentiating For In Vitro Diagnostic Use (Class II - Special Controls, product code KSG).
Submitted by Biological Corp. of America (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 47 days after receiving the submission on August 7, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.9600.
| 510(k) Number | K812222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1981 |
| Decision Date | September 23, 1981 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KSG — Media, Potentiating For In Vitro Diagnostic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9600 |