The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Ethyl Alcohol Calibrators And Controls.
| Device ID | K903152 |
| 510k Number | K903152 |
| Device Name: | EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS |
| Classification | Calibrators, Drug Mixture |
| 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 | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-18 |
| Decision Date | 1990-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768002007 | K903152 | 000 |
| 00842768001994 | K903152 | 000 |
| 00842768001987 | K903152 | 000 |
| 00842768001970 | K903152 | 000 |