Cleared Traditional

EASY-TEST LACTIC ACID (LA)

K880787 · Diagnostic Systems · Chemistry
Mar 1988
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K880787 is an FDA 510(k) clearance for the EASY-TEST LACTIC ACID (LA), a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on March 15, 1988, 18 days after receiving the submission on February 26, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K880787 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1988
Decision Date March 15, 1988
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

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