The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) 2000 Phenytoin Assay/calibrators.
| Device ID | K913429 |
| 510k Number | K913429 |
| Device Name: | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-01 |
| Decision Date | 1991-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414561936 | K913429 | 000 |
| 00842768017391 | K913429 | 000 |
| 00842768017384 | K913429 | 000 |