Cleared Traditional

K861010 - VMA BY HPLC TEST (VANILMANDELIC ACID)
(FDA 510(k) Clearance)

K861010 · Bio-Rad · Chemistry

May 1986

Decision

44d

Days

Class 1

Risk

K861010 is an FDA 510(k) clearance for the VMA BY HPLC TEST (VANILMANDELIC ACID), a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Bio-Rad (Richmond, US). The FDA issued a Cleared decision on May 1, 1986, 44 days after receiving the submission on March 18, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number	K861010 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 1986
Decision Date	May 01, 1986
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—