Cleared Traditional

K912321 - MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK

K912321 is the FDA 510(k) clearance for MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK by Nova Biomedical Corp.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K912321 · Nova Biomedical Corp. · Chemistry device
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Jun 1991
Decision
24d
Days
Class 1
Risk

K912321 is an FDA 510(k) clearance for the MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on June 17, 1991 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - 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 K912321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date June 17, 1991
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
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 - JGJ Photometric Method, Magnesium

All 55
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