Cleared Traditional

K843452 - STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ

K843452 is the FDA 510(k) clearance for STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K843452 · Fisher Scientific Co., LLC · Chemistry device
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Sep 1984
Decision
22d
Days
Class 2
Risk

K843452 is an FDA 510(k) clearance for the STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 22 days - a notably fast clearance cycle.

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: 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K843452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date September 27, 1984
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K843452.
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
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K840557 · Shaban Mfg. Co. · Apr 1984
TECHNICON RA-1000 SYSTEM
K833992 · Technicon Instruments Corp. · Jan 1984