The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Oxalate Reagent.
| Device ID | K883525 |
| 510k Number | K883525 |
| Device Name: | OXALATE REAGENT |
| Classification | System, Test, Oxalate |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | LPW |
| CFR Regulation Number | 862.1542 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1988-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516749640 | K883525 | 000 |
| 05391516742177 | K883525 | 000 |
| 05391516742184 | K883525 | 000 |
| 05391516742191 | K883525 | 000 |
| 05391516742207 | K883525 | 000 |
| 05391516742214 | K883525 | 000 |
| 05391516742221 | K883525 | 000 |
| 05391516742238 | K883525 | 000 |
| 05391516742245 | K883525 | 000 |
| 05391516742160 | K883525 | 000 |