Cleared Traditional

K823472 - ULTRA CHEM BAN-UV #65080 & 65081

K823472 is the FDA 510(k) clearance for ULTRA CHEM BAN-UV #65080 & 65081 by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K823472 · Emd Chemicals, Inc. · Chemistry device
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Dec 1982
Decision
36d
Days
Class 2
Risk

K823472 is an FDA 510(k) clearance for the ULTRA CHEM BAN-UV #65080 & 65081. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 36 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K823472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1982
Decision Date December 28, 1982
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 K823472.
ULTRA CHEM BUN-UV #65080-65081
K830241 · Emd Chemicals, Inc. · Apr 1983
AMRESCO UREA NITROGEN REAGENT SET
K830555 · Amresco, Inc. · Mar 1983
BUN-UN CENTRIFICHUM 500, #65080/81
K823300 · Emd Chemicals, Inc. · Jan 1983
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
K823402 · Emd Chemicals, Inc. · Dec 1982
LANCER MSA BUN DIAG. KIT
K821562 · Sherwood Medical Co. · Jun 1982
BLOOD UREA NITROGEN(BUN-UV)
K812417 · Reagents Applications, Inc. · Sep 1981