K792377 is an FDA 510(k) clearance for the CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 305 days after receiving the submission on November 26, 1979.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K792377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1979 |
| Decision Date | September 26, 1980 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |