Cleared Traditional

K971967 - BUN

K971967 is an FDA 510(k) clearance for BUN, manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K971967 · Carolina Liquid Chemistries Corp. · Chemistry device
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Jun 1997
Decision
20d
Days
Class 2
Risk

K971967 is an FDA 510(k) clearance for the BUN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Carolina Liquid Chemistries Corp. devices

FDA 510(k) Submission Details - K971967

510(k) Number K971967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1997
Decision Date June 17, 1997
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 100
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K971967.
IL TEST UREA NITROGEN
K974337 · Instrumentation Laboratory CO · Dec 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931 · Diagnostic Chemicals , Ltd. · Nov 1997
BUN (LIQUID) REAGENT SET
K972671 · Pointe Scientific, Inc., · Jul 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477 · Trace America, Inc. · May 1997
UREA NITROGEN (BUN) LIQUI-UV
K962418 · Stanbio Laboratory · Dec 1996
ROCHE REAGENT FOR BUN
K954000 · Roche Diagnostic Systems, Inc. · Oct 1995