Cleared Traditional

K844473 - HAND-HELD SLIDE READER

K844473 is an FDA 510(k) clearance for HAND-HELD SLIDE READER, manufactured by Portable Medical Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LIB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K844473 · Portable Medical Laboratories, Inc. · Microbiology device
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Jan 1985
Decision
46d
Days
Class 1
Risk

K844473 is an FDA 510(k) clearance for the HAND-HELD SLIDE READER. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Portable Medical Laboratories, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 46 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 Portable Medical Laboratories, Inc. devices

FDA 510(k) Submission Details - K844473

510(k) Number K844473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date January 04, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 30
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