Cleared Traditional

K802337 - PHADEBACT PNEUMOCOCCUS TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K802337 · Pharmacia, Inc. · Microbiology device
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Oct 1980
Decision
35d
Days
Class 1
Risk

K802337 is an FDA 510(k) clearance for the PHADEBACT PNEUMOCOCCUS TEST. Classified as Antisera, All Types, Streptococcus Pneumoniae (product code GWC), Class I - General Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia, Inc. devices

Submission Details

510(k) Number K802337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1980
Decision Date October 31, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWC Antisera, All Types, Streptococcus Pneumoniae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.