Cleared Traditional

K954546 - BLOOD GAS MIXTURE

K954546 is the FDA 510(k) clearance for BLOOD GAS MIXTURE by Liquid Technology Corp.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K954546 · Liquid Technology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
90d
Days
Class 2
Risk

K954546 is an FDA 510(k) clearance for the BLOOD GAS MIXTURE. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Liquid Technology Corp. (Orlando, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Liquid Technology Corp. devices

Submission Details

510(k) Number K954546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date December 28, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 67
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K954546.
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · Beckman Coulter, Inc. · Dec 1998
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · Pointe Scientific, Inc., · May 1997
WAKO DIRECT HDL-C
K963847 · Wako Chemicals USA, Inc. · Dec 1996
SYNCHRON ENZYME VALIDATOR SET
K951964 · Beckman Instruments, Inc. · Jun 1995
IMX ESTRADIOL
K951629 · Abbott Laboratories · May 1995
DC-LINEATE CAT. NO. SE-091
K932555 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1993