Cleared Traditional

K842772 - PHARMACIA B2-MICRO RIA

K842772 is an FDA 510(k) clearance for PHARMACIA B2-MICRO RIA, manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code JGZ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K842772 · Pharmacia, Inc. · Immunology device
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Nov 1984
Decision
108d
Days
Class 2
Risk

K842772 is an FDA 510(k) clearance for the PHARMACIA B2-MICRO RIA. Classified as O-phthalaldehyde, Urea Nitrogen (product code JGZ), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1770 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K842772

510(k) Number K842772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date November 01, 1984
Days to Decision 108 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 105d · This submission: 108d
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 Immunology 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 K842772.
COBAS READY BUN REAGENT
K896236 · Roche Diagnostic Systems, Inc. · Feb 1990
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327 · Heraeus Kulzer, Inc. · Jan 1989
IQ UREA NITROGEN
K863901 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1986
BLOOD UREA NITROGEN REAGENT SYS
K840213 · Sclavo, Inc. · Mar 1984
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418 · King Diagnostics, Inc. · Mar 1982
UREA NITROGEN, KINETIC
K810087 · Bio-Analytics Laboratories, Inc. · Feb 1981