Cleared Traditional

K883327 - CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST

K883327 is an FDA 510(k) clearance for CLINISTAT BUN (BLOOD UREA NITROGEN) REA..., manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code JGZ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K883327 · Heraeus Kulzer, Inc. · Chemistry device
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Jan 1989
Decision
168d
Days
Class 2
Risk

K883327 is an FDA 510(k) clearance for the CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST. Classified as O-phthalaldehyde, Urea Nitrogen (product code JGZ), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 23, 1989 after a review of 168 days - an extended review 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: 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K883327

510(k) Number K883327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1988
Decision Date January 23, 1989
Days to Decision 168 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
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGZ Device Classification - Class 2, Special Controls

Product Code JGZ O-phthalaldehyde, 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 - JGZ O-phthalaldehyde, Urea Nitrogen

All 9
Devices cleared under the same product code (JGZ) and FDA review panel - the closest regulatory comparables to K883327.
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
K904049 · Roche Diagnostic Systems, Inc. · Oct 1990
COBAS READY BUN REAGENT
K896236 · Roche Diagnostic Systems, Inc. · Feb 1990
IQ UREA NITROGEN
K863901 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1986
PHARMACIA B2-MICRO RIA
K842772 · Pharmacia, Inc. · Nov 1984
BLOOD UREA NITROGEN REAGENT SYS
K840213 · Sclavo, Inc. · Mar 1984
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418 · King Diagnostics, Inc. · Mar 1982