Cleared Traditional

NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU (K833153) - FDA 510(k) Clearance

Class I Chemistry device.

K833153 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
71d
Days
Class 1
Risk

K833153 is an FDA 510(k) clearance for the NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU. 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 November 25, 1983 after a review of 71 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

Submission Details

510(k) Number K833153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1983
Decision Date November 25, 1983
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.