Cleared Traditional

K863481 - MODIFICATION OF ACCU-CHEK II (FDA 510(k) Clearance)

K863481 · Boehringer Mannheim Corp. · Chemistry device
Apr 1987
Decision
210d
Days
Class 2
Risk

K863481 is an FDA 510(k) clearance for the MODIFICATION OF ACCU-CHEK II. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 7, 1987, 210 days after receiving the submission on September 9, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K863481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date April 07, 1987
Days to Decision 210 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