Cleared Traditional

K800724 - AMES LAB MANAGEMENT SYSTEM

K800724 is the FDA 510(k) clearance for AMES LAB MANAGEMENT SYSTEM by Miles Laboratories, Inc.. It is a Class 1 Microbiology device (product code JQP) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800724 · Miles Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
15d
Days
Class 1
Risk

K800724 is an FDA 510(k) clearance for the AMES LAB MANAGEMENT SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2100 - 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K800724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1980
Decision Date April 16, 1980
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 48
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K800724.
K 750 COMPUTER/DATA PROCESSOR
K801091 · J.T. Baker Chemical Co. · Jun 1980
CENTRIFICHEM SYSTEM 400
K801167 · Union Carbide Corp. · Jun 1980
IL88640 & 88641 CASSETTE-TAPE PROGRAM
K801131 · Instrumentation Laboratory CO · May 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · Instrumentation Laboratory CO · Mar 1980
3388 REPORTING INTEGRATOR
K792158 · Hewlett-Packard Co. · Nov 1979
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · Syva Co. · Nov 1979