Cleared Traditional

K833154 - NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM

K833154 is an FDA 510(k) clearance for NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM, manufactured by Nova Biomedical Corp.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K833154 · Nova Biomedical Corp. · Chemistry device
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Dec 1983
Decision
84d
Days
Class 1
Risk

K833154 is an FDA 510(k) clearance for the NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K833154

510(k) Number K833154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date December 08, 1983
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 44
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K833154.
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · Instrumentation Laboratory CO · Dec 1984
QCA CHEMISTRY ANALYZER
K833998 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
SHABAN 9865 IL#78637 JUNCTION BLOC
K833804 · Shaban Mfg. Co. · Jan 1984
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
K833153 · Nova Biomedical Corp. · Nov 1983
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
K831227 · Worthington Diagnostic Systems · Jun 1983
RAPID CHEM ANALYZER II
K830095 · Macomb Chemical Co. · Jan 1983