The following data is part of a premarket notification filed by Bio-rad with the FDA for Vma By Hplc Test (vanilmandelic Acid).
| Device ID | K861010 |
| 510k Number | K861010 |
| Device Name: | VMA BY HPLC TEST (VANILMANDELIC ACID) |
| Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
| Applicant | BIO-RAD 2400 WRIGHT AVE. Richmond, CA 94804 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 2400 WRIGHT AVE. Richmond, CA 94804 |
| Product Code | CDF |
| CFR Regulation Number | 862.1795 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-05-01 |