Cleared Traditional

K843530 - CORNING 614 NA/K ANALYZER

K843530 is the FDA 510(k) clearance for CORNING 614 NA/K ANALYZER by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K843530 · Corning Medical & Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
95d
Days
Class 2
Risk

K843530 is an FDA 510(k) clearance for the CORNING 614 NA/K ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Medfield, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K843530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date December 11, 1984
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 111
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K843530.
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET
K861967 · American Research Products Co. · Jun 1986
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
K843452 · Fisher Scientific Co., LLC · Sep 1984
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025 · Hi Chem, Inc. · Jun 1984