The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit-tox Serum Tricyclic Antidepr. Assay.
| Device ID | K821743 |
| 510k Number | K821743 |
| Device Name: | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-14 |
| Decision Date | 1982-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014321 | K821743 | 000 |
| 00842768014314 | K821743 | 000 |