The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Creatinine.
| Device ID | K003247 |
| 510k Number | K003247 |
| Device Name: | CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| 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 | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2000-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274022337 | K003247 | 000 |
| 00817274021446 | K003247 | 000 |
| 00817274021439 | K003247 | 000 |
| 00817274021422 | K003247 | 000 |
| 00817274021415 | K003247 | 000 |
| 00817274021408 | K003247 | 000 |
| 00817274021392 | K003247 | 000 |
| 00817274021385 | K003247 | 000 |
| 00817274021378 | K003247 | 000 |