Cleared Traditional

K901808 - MICROMATE 196 MODEL A961960

K901808 is an FDA 510(k) clearance for MICROMATE 196 MODEL A961960, manufactured by Packard Instrument Co., Inc.. The device is a Class 1 Microbiology device with product code JTC cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K901808 · Packard Instrument Co., Inc. · Microbiology device
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Jun 1990
Decision
61d
Days
Class 1
Risk

K901808 is an FDA 510(k) clearance for the MICROMATE 196 MODEL A961960. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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.

FDA 510(k) Submission Details - K901808

510(k) Number K901808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date June 20, 1990
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 102d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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 - JTC Device, Microtiter Diluting/dispensing

All 65
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K901808.
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K891766 · Genetic Systems Corp. · May 1989
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · Genetic Systems Corp. · May 1989
K901808 · MICROMATE 196 MODEL A961960
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