Cleared Traditional

K844476 - PORTABLE DIAGNOSTIC LABORATORY

K844476 is an FDA 510(k) clearance for PORTABLE DIAGNOSTIC LABORATORY, manufactured by Portable Medical Laboratories, Inc.. The device is a Class 1 Chemistry device with product code LIB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K844476 · Portable Medical Laboratories, Inc. · Chemistry device
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Mar 1985
Decision
114d
Days
Class 1
Risk

K844476 is an FDA 510(k) clearance for the PORTABLE DIAGNOSTIC LABORATORY. 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 March 13, 1985 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K844476

510(k) Number K844476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date March 13, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 89d · This submission: 114d
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 42
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K844476.
MYWASHER 5
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MIC-CONCEPT VIEWBOX
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QUADRA TITER MICRO PLATES
K850725 · Microtech Medical Systems, Inc. · Apr 1985
RAPID DIAGNOSTIC KIT
K844442 · Portable Medical Laboratories, Inc. · Feb 1985
HAND-HELD SLIDE READER
K844473 · Portable Medical Laboratories, Inc. · Jan 1985
PHARMA-PLAST PETRI DISH
K843483 · Zimmar Consulting , Ltd. · Sep 1984
K844476 · PORTABLE DIAGNOSTIC LABORATORY
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