The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 2000 Phenobarbital Assay, Model Osr4d229.
| Device ID | K011528 |
| 510k Number | K011528 |
| Device Name: | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Susan Collins |
| Correspondent | Susan Collins SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023224 | K011528 | 000 |