Cleared Traditional

VIRGO(R) MICROWELL ALT ASSAY

K884784 · Electro-Nucleonics, Inc. · Chemistry
Dec 1988
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K884784 is an FDA 510(k) clearance for the VIRGO(R) MICROWELL ALT ASSAY, a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on December 29, 1988, 44 days after receiving the submission on November 15, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K884784 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1988
Decision Date December 29, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKD — Hydrazone Colorimetry, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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