The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Iic Negative Control, Control I And Ii.
| Device ID | K935230 |
| 510k Number | K935230 |
| Device Name: | EMIT IIC NEGATIVE CONTROL, CONTROL I AND II |
| Classification | Drug Mixture Control Materials |
| Applicant | SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Contact | Paul Rogers |
| Correspondent | Paul Rogers SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-01-03 |