The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Cr Perfect.
| Device ID | K970087 |
| 510k Number | K970087 |
| Device Name: | CR PERFECT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | CHIMERA RESEARCH & CHEMICAL, INC. 4309 TYSON AVENUE WEST Tampa, FL 33681 |
| Contact | Charles A Hay, Ph.d. |
| Correspondent | Charles A Hay, Ph.d. CHIMERA RESEARCH & CHEMICAL, INC. 4309 TYSON AVENUE WEST Tampa, FL 33681 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1997-03-06 |