Cleared Traditional

K840476 - PHADEXACT SERUM

K840476 is the FDA 510(k) clearance for PHADEXACT SERUM by Pharmacia, Inc.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K840476 · Pharmacia, Inc. · Chemistry device
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May 1984
Decision
108d
Days
Class 2
Risk

K840476 is an FDA 510(k) clearance for the PHADEXACT SERUM, TOTAL IGE CONTROLS. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K840476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date May 21, 1984
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 81
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K840476.
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · Pharmacia, Inc. · Jun 1984
ALLERCOAT ALLERGEN DISCS
K842125 · Kallestad Laboratories, Inc. · Jun 1984
VAST VENTREX RAST ALL
K841651 · Ventrex Laboratories, Inc. · Jun 1984
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983