Cleared Traditional

K897183 - SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS

K897183 is an FDA 510(k) clearance for SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code JFL cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K897183 · Beckman Instruments, Inc. · Chemistry device
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Mar 1990
Decision
92d
Days
Class 2
Risk

K897183 is an FDA 510(k) clearance for the SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 92 days - within the typical 510(k) review window.

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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K897183

510(k) Number K897183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date March 30, 1990
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 21
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K897183.
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co. · Oct 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · Hichem Diagnostics · Feb 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · Hichem Diagnostics · Feb 1993
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · American Research Products Co. · Mar 1990
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · Shaban Mfg. Co. · Aug 1984
LIQUIZYME CO2REAGENT SET
K820388 · American Research Products Co. · Mar 1982