Cleared Traditional

K863188 - HPL RIA KIT
(FDA 510(k) Clearance)

K863188 · Biotecx Laboratories, Inc. · Chemistry
Sep 1986
Decision
37d
Days
Class 1
Risk

K863188 is an FDA 510(k) clearance for the HPL RIA KIT. This device is classified as a Ninhydrin, Nitrogen (amino-nitrogen) (Class I — General Controls, product code JMX).

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on September 25, 1986, 37 days after receiving the submission on August 19, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1515.

Submission Details

510(k) Number K863188 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1986
Decision Date September 25, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMX — Ninhydrin, Nitrogen (amino-nitrogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1515