Cleared Traditional

K883327 - CLINISTAT BUN (BLOOD UREA NITROGEN) REA...

K883327 is the FDA 510(k) clearance for CLINISTAT BUN (BLOOD UREA NITROGEN) REA... by Heraeus Kulzer, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

Device Classification

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 8
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