Cleared Traditional

IRON QVET (K943029) - FDA 510(k) Clearance

Class I Chemistry device.

K943029 · Prisma Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
158d
Days
Class 1
Risk

K943029 is an FDA 510(k) clearance for the IRON QVET. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 Prisma Systems devices

Submission Details

510(k) Number K943029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date December 02, 1994
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

All 66
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K943029.
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K930166 · Em Diagnostic Systems, Inc. · Apr 1993