Cleared Traditional

K901965 - MPR-4A - MICRO-PLATE READER

K901965 is an FDA 510(k) clearance for MPR-4A - MICRO-PLATE READER, manufactured by Tosoh Corp.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K901965 · Tosoh Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
10d
Days
Class 1
Risk

K901965 is an FDA 510(k) clearance for the MPR-4A - MICRO-PLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on May 10, 1990 after a review of 10 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 Tosoh Corp. devices

FDA 510(k) Submission Details - K901965

510(k) Number K901965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date May 10, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 K901965.
GEN-PROBE LUMINOMETER-LEADER 50
K903934 · Gen-Probe, Inc. · Sep 1990
BEHRING CHROMOTIMER
K901829 · Behring Diagnostics, Inc. · Jul 1990
QUICK CHEM II
K901695 · Seradyn, Inc. · May 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
K901027 · Bio-Tek Instruments, Inc. · Apr 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
K901059 · Bio-Tek Instruments, Inc. · Apr 1990