The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Creatinine Reagent.
| Device ID | K902172 |
| 510k Number | K902172 |
| Device Name: | COULTER CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Benita Bradford |
| Correspondent | Benita Bradford COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-14 |
| Decision Date | 1990-06-28 |