Cleared Traditional

EXACTECH(TM)

K863468 · Travenol Laboratories, S.A. · Chemistry
Dec 1986
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K863468 is an FDA 510(k) clearance for the EXACTECH(TM), a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on December 8, 1986, 91 days after receiving the submission on September 8, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K863468 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1986
Decision Date December 08, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

Similar Devices — CGA Glucose Oxidase, Glucose

All 399
YSI 2900C Biochemistry Analyzer
K210933 · Ysi, Inc. · Sep 2024
EasyStat 300
K220328 · Medica Corporation · Jul 2024
Cholestech LDX ? System
K223179 · Alere San Diego, Inc. · Sep 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · Abbott Point of Care, Inc. · Sep 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc. · Jul 2023
GEM Premier ChemSTAT
K223090 · Instrumentation Laboratory CO · Jan 2023