The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Uric Acid Liquid Reagent.
| Device ID | K012038 |
| 510k Number | K012038 |
| Device Name: | JAS URIC ACID LIQUID REAGENT |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-29 |
| Decision Date | 2001-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274022191 | K012038 | 000 |
| 00817274022184 | K012038 | 000 |
| 00817274022177 | K012038 | 000 |
| 00817274022160 | K012038 | 000 |
| 00817274022153 | K012038 | 000 |
| 00817274022146 | K012038 | 000 |
| 00817274022139 | K012038 | 000 |
| 00817274022122 | K012038 | 000 |
| 00817274022115 | K012038 | 000 |