Cleared Traditional

K840962 - REFLOCHECK-S

K840962 is an FDA 510(k) clearance for REFLOCHECK-S, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K840962 · Boehringer Mannheim Corp. · Chemistry device
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Jun 1984
Decision
108d
Days
Class 2
Risk

K840962 is an FDA 510(k) clearance for the REFLOCHECK-S. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K840962

510(k) Number K840962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date June 22, 1984
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 206
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K840962.
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
WAKO B.G. PRETEST STRIPS
K842207 · Healthdyne, Inc. · Jun 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · Medical Specialties, Inc. · May 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983