Cleared Traditional

K943006 - CHLORIDE QVET

K943006 is an FDA 510(k) clearance for CHLORIDE QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code CHJ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K943006 · Prisma Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
167d
Days
Class 2
Risk

K943006 is an FDA 510(k) clearance for the CHLORIDE QVET. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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

FDA 510(k) Submission Details - K943006

510(k) Number K943006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 07, 1994
Days to Decision 167 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
79d slower than avg
Panel avg: 88d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHJ Device Classification - Class 2, Special Controls

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 42
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K943006.
340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
K945408 · Catachem, Inc. · Feb 1995
OLYMPUS CHLORIDE REAGENT, MODIFICATION
K934136 · Olympus Corp. · Nov 1993
OLYMPUS CHLORID REAGENT, MODIFIED
K932528 · Olympus Corp. · Sep 1993
OLYMPUS CHLORIDE REAGENT
K925338 · Olympus Corp. · Dec 1992
KING DIAGNOSTICS CHLORIDE REAGENT
K922921 · King Diagnostics, Inc. · Oct 1992
OLYMPUS CHLORIDE REAGENT
K923610 · Olympus Corp. · Oct 1992