Cleared Traditional

SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT

K863842 · Miles Laboratories, Inc. · Toxicology
Jan 1987
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K863842 is an FDA 510(k) clearance for the SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 14, 1987, 105 days after receiving the submission on October 1, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K863842 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1986
Decision Date January 14, 1987
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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