The following data is part of a premarket notification filed by Bioanalytical Systems, Inc. with the FDA for Plasma Catecholamine Kit.
| Device ID | K972167 |
| 510k Number | K972167 |
| Device Name: | PLASMA CATECHOLAMINE KIT |
| Classification | Chromatographic/fluorometric Method, Catecholamines |
| Applicant | BIOANALYTICAL SYSTEMS, INC. 2701 KENT AVE. West Lafayette, IN 47906 |
| Contact | Stephen Geary |
| Correspondent | Stephen Geary BIOANALYTICAL SYSTEMS, INC. 2701 KENT AVE. West Lafayette, IN 47906 |
| Product Code | CHQ |
| CFR Regulation Number | 862.1165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-08-04 |
| Summary: | summary |