The following data is part of a premarket notification filed by Bio-rad with the FDA for Urinary Free Catecholamines & Metanephrines (hplc).
| Device ID | K873371 |
| 510k Number | K873371 |
| Device Name: | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) |
| Classification | Chromatographic/fluorometric Method, Catecholamines |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | CHQ |
| CFR Regulation Number | 862.1165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1988-01-05 |