The following data is part of a premarket notification filed by Bio-rad with the FDA for Hva & Homovanillic Acid By Hplc Method.
Device ID | K873372 |
510k Number | K873372 |
Device Name: | HVA & HOMOVANILLIC ACID BY HPLC METHOD |
Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
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 | CDF |
CFR Regulation Number | 862.1795 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-24 |
Decision Date | 1987-12-22 |