Cleared Traditional

K864060 - MICRO-READER

K864060 is the FDA 510(k) clearance for MICRO-READER by Hyperion, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K864060 · Hyperion, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
39d
Days
Class 1
Risk

K864060 is an FDA 510(k) clearance for the MICRO-READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Hyperion, Inc. (Miami, US). The FDA issued a Cleared decision on November 28, 1986 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Hyperion, Inc. devices

Submission Details

510(k) Number K864060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1986
Decision Date November 28, 1986
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K864060.
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · Ohmeda Medical · Jan 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
BEHRING RAPIMAT II
K861263 · Behring Diagnostics, Inc. · Oct 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986