Cleared Traditional

K833257 - WAKO GLUCOSE C

K833257 is the FDA 510(k) clearance for WAKO GLUCOSE C by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K833257 · Wako Chemicals USA, Inc. · Chemistry device
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Dec 1983
Decision
79d
Days
Class 2
Risk

K833257 is an FDA 510(k) clearance for the WAKO GLUCOSE C. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K833257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1983
Decision Date December 08, 1983
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K833257.
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · Medical Specialties, Inc. · May 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · Stanbio Laboratory · Aug 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983