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 |