Cleared Traditional

VANILMANDELIC ACID (VMA) REAGENT SET

K861962 · Sterling Diagnostics, Inc. · Chemistry
Jul 1986
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K861962 is an FDA 510(k) clearance for the VANILMANDELIC ACID (VMA) REAGENT SET, a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on July 7, 1986, 48 days after receiving the submission on May 20, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number K861962 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1986
Decision Date July 07, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDF — Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1795

Similar Devices — CDF Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin

All 11
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
K953077 · Beckman Instruments, Inc. · Jan 1996
MODEL 5500 CEAS
K934977 · Esa, Inc. · Jan 1994
HVA EIA KIT YAMASA
K895288 · Yamasa Shoy Co., Ltd. · Oct 1989
VMA EIA KIT YAMASA
K895287 · Yamasa Shoy Co., Ltd. · Oct 1989
HVA & HOMOVANILLIC ACID BY HPLC METHOD
K873372 · Bio-Rad · Dec 1987
VMA BY HPLC TEST (VANILMANDELIC ACID)
K861010 · Bio-Rad · May 1986