The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Oxalate Urine Controls Normal & Elevat.
| Device ID | K842366 |
| 510k Number | K842366 |
| Device Name: | OXALATE URINE CONTROLS NORMAL & ELEVAT |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | SIGMA CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743204 | K842366 | 000 |
| 05391516743198 | K842366 | 000 |