Cleared Traditional

K900420 - BICARBONATE REAGENTS PRODUCT #7713 & #7714

K900420 is the FDA 510(k) clearance for BICARBONATE REAGENTS PRODUCT #7713 & #7714 by American Research Products Co.. It is a Class 2 Chemistry device (product code JFL) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K900420 · American Research Products Co. · Chemistry device
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Mar 1990
Decision
30d
Days
Class 2
Risk

K900420 is an FDA 510(k) clearance for the BICARBONATE REAGENTS PRODUCT #7713 & #7714. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 30 days - a notably fast clearance 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: 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 American Research Products Co. devices

Submission Details

510(k) Number K900420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date March 01, 1990
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K900420.
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
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · Beckman Instruments, Inc. · Mar 1990
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · Shaban Mfg. Co. · Aug 1984
LIQUIZYME CO2REAGENT SET
K820388 · American Research Products Co. · Mar 1982
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · J.T. Baker Chemical Co. · Sep 1980