Cleared Traditional

REFLOTRON(R) ALT (GPT)

K864082 · Boehringer Mannheim Corp. · Chemistry
Dec 1986
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K864082 is an FDA 510(k) clearance for the REFLOTRON(R) ALT (GPT), a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on December 4, 1986, 45 days after receiving the submission on October 20, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K864082 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1986
Decision Date December 04, 1986
Days to Decision 45 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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