Cleared Traditional

K842772 - PHARMACIA B2-MICRO RIA

K842772 is the FDA 510(k) clearance for PHARMACIA B2-MICRO RIA by Pharmacia, Inc.. It is a Class 2 Immunology device (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

Submission Details

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
4d slower than avg
Panel avg: 104d · This submission: 108d
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 Immunology 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 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
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269 · Miles Laboratories, Inc. · Jul 1980