Cleared Traditional

K823512 - MR 600 MICROPLATE READER

K823512 is an FDA 510(k) clearance for MR 600 MICROPLATE READER, manufactured by Laboratory and Medical Products Group. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K823512 · Laboratory and Medical Products Group · Chemistry device
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Mar 1983
Decision
92d
Days
Class 1
Risk

K823512 is an FDA 510(k) clearance for the MR 600 MICROPLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Laboratory and Medical Products Group (Mchenry, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Laboratory and Medical Products Group devices

FDA 510(k) Submission Details - K823512

510(k) Number K823512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1982
Decision Date March 01, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K823512.
PHOTON IMMUNOASSAY ANALYZER
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SPECTROPHOTOMETER #390
K832206 · Abbott Diagnostics · Aug 1983
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · Varian Assoc., Inc. · Jul 1983
MANUALISA MICROTITRATION PLATE READER
K823590 · Ortho Diagnostic Systems, Inc. · Feb 1983
COLORIMETERS SERIES ONE 12
K830101 · Innotron of Oregon, Inc. · Jan 1983
SPECTROPHOTOMETER
K823720 · Macomb Chemical Co. · Jan 1983