Cleared Traditional

K792482 - CHEMISTRY ANALYZER REAGENTS

K792482 is the FDA 510(k) clearance for CHEMISTRY ANALYZER REAGENTS by Laboratory Products, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K792482 · Laboratory Products, Inc. · Chemistry device
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Jan 1980
Decision
53d
Days
Class 2
Risk

K792482 is an FDA 510(k) clearance for the CHEMISTRY ANALYZER REAGENTS. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 Laboratory Products, Inc. devices

Submission Details

510(k) Number K792482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date January 11, 1980
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 80
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K792482.
AMES SERA-PAK ALBUMIN REAGENT KIT
K803237 · Miles Laboratories, Inc. · Jan 1981
CENTRIFICHEM ALBUMIN
K802436 · Union Carbide Corp. · Oct 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980
ELVI ALBUMIN
K792408 · Volu Sol Medical Industries · Dec 1979
ALBUMIN REAGENT
K781773 · Gilford Diagnostics · Nov 1978
ULTRACHEM ALBUMIN
K780092 · Harleco · Feb 1978