Cleared Traditional

K841423 - SCOTTS TAP WATER SUBSTITUTE 7

K841423 is an FDA 510(k) clearance for SCOTTS TAP WATER SUBSTITUTE 7, manufactured by Reagent Laboratory, Inc.. The device is a Class 1 Pathology device with product code JCC cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K841423 · Reagent Laboratory, Inc. · Pathology device
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May 1984
Decision
47d
Days
Class 1
Risk

K841423 is an FDA 510(k) clearance for the SCOTTS TAP WATER SUBSTITUTE 7. Classified as Ph Buffer (product code JCC), Class I - General Controls.

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology device 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.

FDA 510(k) Submission Details - K841423

510(k) Number K841423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1984
Decision Date May 22, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 78d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

JCC Device Classification - Class 1, General Controls

Product Code JCC Ph Buffer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JCC Ph Buffer

Devices cleared under the same product code (JCC) and FDA review panel - the closest regulatory comparables to K841423.
SCOTTS TAP WATER SUBSTITUTE
K842918 · E K Ind., Inc. · Sep 1984
WRIGHT STAIN BUFFER
K842914 · E K Ind., Inc. · Sep 1984
PHOSPHATE BUFFERED SALINE (1X)
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CITRATE BUFFER
K811251 · Bioscientific · May 1981
MOPSO BUFFER
K792574 · Electrophoresis Corp. of America · Jan 1980
SMAC SYSTEM
K770508 · Mid Tech, Inc. · May 1977
K841423 · SCOTTS TAP WATER SUBSTITUTE 7
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