The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit (r) Tox Salicylic Assay, Model 7so19ul, Emit (r) Tox Salicylic Acid Calibrators, Model 7s109ul.
| Device ID | K011878 |
| 510k Number | K011878 |
| Device Name: | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
| Classification | Colorimetry, Salicylate |
| Applicant | SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Contact | Susan L Collins |
| Correspondent | Susan L Collins SYVA CO. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-15 |
| Decision Date | 2001-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023347 | K011878 | 000 |
| 00842768001628 | K011878 | 000 |
| 00842768001611 | K011878 | 000 |