Cleared Traditional

K873372 - HVA & HOMOVANILLIC ACID BY HPLC METHOD
(FDA 510(k) Clearance)

K873372 · Bio-Rad · Chemistry
Dec 1987
Decision
120d
Days
Class 1
Risk

K873372 is an FDA 510(k) clearance for the HVA & HOMOVANILLIC ACID BY HPLC METHOD, a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 22, 1987, 120 days after receiving the submission on August 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number K873372 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1987
Decision Date December 22, 1987
Days to Decision 120 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

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