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 |