Cleared Traditional

K782086 - AM-PEN SCREEN

K782086 is the FDA 510(k) clearance for AM-PEN SCREEN by Pfizer, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K782086 · Pfizer, Inc. · Microbiology device
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Feb 1979
Decision
49d
Days
Class 1
Risk

K782086 is an FDA 510(k) clearance for the AM-PEN SCREEN. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Pfizer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Pfizer, Inc. devices

Submission Details

510(k) Number K782086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1978
Decision Date February 01, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 145
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K782086.
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DISK, BETA-LACTAM
K790038 · Remel Co. · Jan 1979
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K781567 · Analytical Products, Inc. · Dec 1978
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K770926 · Analytical Products, Inc. · Jun 1977