Cleared Traditional

K892063 - THERMOMAX MICROPLATE READER, MODIFICATION

K892063 is an FDA 510(k) clearance for THERMOMAX MICROPLATE READER, manufactured by Molecular Devices Corp.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K892063 · Molecular Devices Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
42d
Days
Class 1
Risk

K892063 is an FDA 510(k) clearance for the THERMOMAX MICROPLATE READER, MODIFICATION. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Molecular Devices Corp. (Menlo Park, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 42 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 Molecular Devices Corp. devices

FDA 510(k) Submission Details - K892063

510(k) Number K892063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1989
Decision Date May 11, 1989
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K892063.
DYNATECH MR 5000, CATALOG #011-976-0600
K894687 · Dynatech Laboratories, Inc. · Aug 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · Quidel Corp. · Aug 1989
MICROTRAK EIA AUTOREADER
K891270 · Syva Co. · Jun 1989
EIA READER MODEL EL301
K890854 · Bio-Tek Instruments, Inc. · Mar 1989
MICROLITE TUBE LUMINOMETER #011-902-0000
K890502 · Dynatech Laboratories, Inc. · Feb 1989
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782 · Dynatech Laboratories, Inc. · Feb 1989