The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Phenobarbital Assay System.
Device ID | K864612 |
510k Number | K864612 |
Device Name: | DART PHENOBARBITAL ASSAY SYSTEM |
Classification | Nephelometric Inhibition Immunoassay, Phenobarbital |
Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Contact | Richardson-jones |
Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
Product Code | LFN |
CFR Regulation Number | 862.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-24 |
Decision Date | 1987-01-13 |