K820900 is an FDA 510(k) clearance for the EMIT URINE METHADONE ASSAY #3E319. This device is classified as a Carbonic Anhydrase C, Antigen, Antiserum, Control (Class I - General Controls, product code DDE).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982, 26 days after receiving the submission on March 31, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5200.
| 510(k) Number | K820900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1982 |
| Decision Date | April 26, 1982 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DDE — Carbonic Anhydrase C, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5200 |