Cleared Traditional

K854303 - MR 700 MICROPLATE READER 012-700-1000

K854303 is the FDA 510(k) clearance for MR 700 MICROPLATE READER 012-700-1000 by Dynatech Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K854303 · Dynatech Laboratories, Inc. · Chemistry device
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Nov 1985
Decision
25d
Days
Class 1
Risk

K854303 is an FDA 510(k) clearance for the MR 700 MICROPLATE READER 012-700-1000. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Alexandria, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 25 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 Dynatech Laboratories, Inc. devices

Submission Details

510(k) Number K854303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 19, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K854303.
ULTROSPEC K KINETICS SPECTROPHOTOMETER
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RAICHEM/K.E
K854540 · Reagents Applications, Inc. · Nov 1985
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)
K852411 · Dynatech Laboratories, Inc. · Sep 1985
LKB 4057 ULTROSPEC II E
K852538 · Lkb Instruments, Inc. · Sep 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · Em Diagnostic Systems, Inc. · Aug 1985