The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Txit D.a.u. Barbiturate Assay (modification).
| Device ID | K920314 |
| 510k Number | K920314 |
| Device Name: | TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | SYNTEX CORP. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYNTEX CORP. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-23 |
| Decision Date | 1992-04-17 |