The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Salicylate Assay.
| Device ID | K961131 |
| 510k Number | K961131 |
| Device Name: | SALICYLATE ASSAY |
| Classification | Colorimetry, Salicylate |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay, Ph.d. |
| Correspondent | Yuh-geng Tsay, Ph.d. DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001152 | K961131 | 000 |
| 00884883001145 | K961131 | 000 |