Cleared Traditional

K821807 - AMERIFLOUR FLUOROMETER

K821807 is the FDA 510(k) clearance for AMERIFLOUR FLUOROMETER by American Diagnostic Corp.. It is a Class 1 Chemistry device (product code JQP) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821807 · American Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
15d
Days
Class 1
Risk

K821807 is an FDA 510(k) clearance for the AMERIFLOUR FLUOROMETER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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: 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K821807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date July 02, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · 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 42
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K821807.
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
K822860 · Ventrex Laboratories, Inc. · Oct 1982
SYVA LAB PROCESSOR 6000
K822381 · Syva Co. · Aug 1982
CORNING 101 PRINTER
K822146 · Corning Medical & Scientific · Aug 1982
EMIT TIMER UNIT #100
K821531 · Syva Co. · Jun 1982
715 DELTA TERMINAL
K821058 · Corning Medical & Scientific · May 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · Instrumentation Laboratory CO · Mar 1982