Cleared Traditional

K911903 - ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA

K911903 is an FDA 510(k) clearance for ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA, manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K911903 · Pharmacia, Inc. · Immunology device
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Aug 1991
Decision
105d
Days
Class 2
Risk

K911903 is an FDA 510(k) clearance for the ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (New Brunswick, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 - K911903

510(k) Number K911903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date August 12, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 231
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