Cleared Traditional

K841915 - PHAMAS ALLERGY MGMT. SYSTEM

K841915 · Pharmacia, Inc. · Microbiology device
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May 1984
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K841915 is an FDA 510(k) clearance for the PHAMAS ALLERGY MGMT. SYSTEM.

Submitted by Pharmacia, Inc. (Walker, US). The FDA issued a Cleared decision on May 9, 1984.

This device falls under the Microbiology FDA review panel. 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K841915

510(k) Number K841915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received May 09, 1984
Decision Date May 09, 1984
Days to Decision -
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -