The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Cr Perfect.
Device ID | K950142 |
510k Number | K950142 |
Device Name: | CR PERFECT |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | CHIMERA RESEARCH & CHEMICAL, INC. 10360 72ND ST. NORTH Largo, FL |
Contact | Jack V Smith |
Correspondent | Jack V Smith CHIMERA RESEARCH & CHEMICAL, INC. 10360 72ND ST. NORTH Largo, FL |
Product Code | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-13 |
Decision Date | 1995-05-25 |