Cleared Traditional

K823537 - GLUCOSE REAGENT

K823537 is an FDA 510(k) clearance for GLUCOSE REAGENT, manufactured by Ac Biochemical Laboratories, Inc.. The device is a Class 2 Chemistry device with product code FMF cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K823537 · Ac Biochemical Laboratories, Inc. · Chemistry device
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Apr 1983
Decision
127d
Days
Class 2
Risk

K823537 is an FDA 510(k) clearance for the GLUCOSE REAGENT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ac Biochemical Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5860 - 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 Ac Biochemical Laboratories, Inc. devices

FDA 510(k) Submission Details - K823537

510(k) Number K823537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1982
Decision Date April 06, 1983
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.