The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Tobramycin Assay.
| Device ID | K874223 |
| 510k Number | K874223 |
| Device Name: | EMIT TOBRAMYCIN ASSAY |
| Classification | Radioimmunoassay, Tobramycin |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | KLB |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-11-13 |