Cleared Traditional

K933696 - SIGMA ELECTROLYTE REFERENCE REAGENT

K933696 is an FDA 510(k) clearance for SIGMA ELECTROLYTE REFERENCE REAGENT, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code JFL cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K933696 · Sigma Chemical Co. · Chemistry device
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Jan 1994
Decision
158d
Days
Class 2
Risk

K933696 is an FDA 510(k) clearance for the SIGMA ELECTROLYTE REFERENCE REAGENT. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K933696

510(k) Number K933696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date January 03, 1994
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFL Device Classification - Class 2, Special Controls

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - JFL Ph Rate Measurement, Carbon-dioxide

All 22
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K933696.
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NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · Nova Biomedical Corp. · Aug 1996
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · Sigma Chemical Co. · Dec 1993
SIGMA CO2 ACID REAGENT
K933692 · Sigma Chemical Co. · Dec 1993
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co. · Oct 1993