Cleared Traditional

K843326 - SYSTEMATE BUN HEM NO. 67221

K843326 is the FDA 510(k) clearance for SYSTEMATE BUN HEM NO. 67221 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843326 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1984
Decision
18d
Days
Class 2
Risk

K843326 is an FDA 510(k) clearance for the SYSTEMATE BUN HEM NO. 67221. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 18 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K843326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date September 14, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 87
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K843326.
BUN (RATE) REAGENT
K850923 · Sigma Diagnostics, Inc. · Mar 1985
FOCUS UREA NITROGEN
K844755 · Abbott Laboratories · Jan 1985
ENI BLOOD UREA NITROGEN REAGENT
K844065 · Electro-Nucleonics Laboratories, Inc. · Nov 1984
UREA ASSAY KIT
K843057 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
UREA ASSAY KIT
K842242 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
PARAMAX UREA NITROGEN REAGENT
K840785 · American Dade · Apr 1984