The following data is part of a premarket notification filed by Dilab, Inc. with the FDA for Creatinine.
| Device ID | K850932 |
| 510k Number | K850932 |
| Device Name: | CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | DILAB, INC. 7003 N.W. 50TH ST. Miami, FL 33166 |
| Contact | Rafael A Quevedo |
| Correspondent | Rafael A Quevedo DILAB, INC. 7003 N.W. 50TH 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 | 1985-03-07 |
| Decision Date | 1985-06-25 |