Cleared Traditional

K873129 - CARBON DIOXIDE REAGENT KIT

K873129 is an FDA 510(k) clearance for CARBON DIOXIDE REAGENT KIT, manufactured by A-Kem, Inc.. The device is a Class 2 Chemistry device with product code JFL cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K873129 · A-Kem, Inc. · Chemistry device
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Oct 1987
Decision
74d
Days
Class 2
Risk

K873129 is an FDA 510(k) clearance for the CARBON DIOXIDE REAGENT KIT. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 74 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 A-Kem, Inc. devices

FDA 510(k) Submission Details - K873129

510(k) Number K873129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date October 23, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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 23
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K873129.
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
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
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · J.T. Baker Chemical Co. · Sep 1980