The following data is part of a premarket notification filed by Clintech Diagnostics Corp. with the FDA for Salicylate Stat-pak.
| Device ID | K813185 |
| 510k Number | K813185 |
| Device Name: | SALICYLATE STAT-PAK |
| Classification | Colorimetry, Salicylate |
| Applicant | CLINTECH DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1981-11-24 |