The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Creatinine.
| Device ID | K830556 |
| 510k Number | K830556 |
| Device Name: | CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Correspondent | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015013 | K830556 | 000 |
| 00811727010988 | K830556 | 000 |
| 00811727010995 | K830556 | 000 |
| 00811727011008 | K830556 | 000 |
| 00811727011015 | K830556 | 000 |
| 00811727012654 | K830556 | 000 |
| 00811727012982 | K830556 | 000 |
| 00811727013491 | K830556 | 000 |
| 00811727014023 | K830556 | 000 |
| 00811727014078 | K830556 | 000 |
| 00811727014085 | K830556 | 000 |
| 00811727014092 | K830556 | 000 |
| 00811727014108 | K830556 | 000 |
| 00811727014115 | K830556 | 000 |
| 00811727014122 | K830556 | 000 |
| 00811727014702 | K830556 | 000 |
| 00811727016119 | K830556 | 000 |