Cleared Traditional

K841420 - SODIUM & POTASSIUM STANDARD SOL 80

K841420 is an FDA 510(k) clearance for SODIUM & POTASSIUM STANDARD SOL 80, manufactured by Reagent Laboratory, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841420 · Reagent Laboratory, Inc. · Chemistry device
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May 1984
Decision
36d
Days
Class 2
Risk

K841420 is an FDA 510(k) clearance for the SODIUM & POTASSIUM STANDARD SOL 80. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Reagent Laboratory, Inc. devices

FDA 510(k) Submission Details - K841420

510(k) Number K841420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1984
Decision Date May 11, 1984
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 275
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K841420.
DOUMENT TM LINEARITY TEST STANDARDS
K843947 · Casco Standards · Oct 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464 · Nova Biomedical Corp. · Jun 1984
SODIUM & POTASSIUM STANDARD SOLUT
K841419 · Reagent Laboratory, Inc. · May 1984
TRIGLYCERIDE/CHOLESTEROL AQUEOUS
K840219 · Preventive Diagnostics Corp. · Mar 1984
HDL CHOLESTEROL CONTROLS-LEVELS
K840278 · Preventive Diagnostics Corp. · Mar 1984
PARAMAX BILIRUBIN CALIBRATORS
K833005 · American Dade · Nov 1983