Cleared Traditional

K851100 - CHEM PRO 1000 CHEMISTRY ANALYSIS

K851100 is an FDA 510(k) clearance for CHEM PRO 1000 CHEMISTRY ANALYSIS, manufactured by Sen Tech Medical Corp.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K851100 · Sen Tech Medical Corp. · Chemistry device
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Jul 1985
Decision
112d
Days
Class 2
Risk

K851100 is an FDA 510(k) clearance for the CHEM PRO 1000 CHEMISTRY ANALYSIS. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Sen Tech Medical Corp. (Arden Hills, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Sen Tech Medical Corp. devices

FDA 510(k) Submission Details - K851100

510(k) Number K851100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date July 09, 1985
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 71
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K851100.
IRON
K854298 · Boehringer Mannheim Corp. · Nov 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · American Dade · Sep 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985
ION 2 REAGENT KI
K851350 · Hi Chem, Inc. · Apr 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · Miles Laboratories, Inc. · Mar 1985
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · Medica Corp. · Nov 1984