Cleared Traditional

K920888 - MICROLITE MICROTITER PLATE LUMINOMETER ...

K920888 is the FDA 510(k) clearance for MICROLITE MICROTITER PLATE LUMINOMETER ... by Dynatech Laboratories, Inc.. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K920888 · Dynatech Laboratories, Inc. · Chemistry device
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Mar 1992
Decision
37d
Days
Class 1
Risk

K920888 is an FDA 510(k) clearance for the MICROLITE MICROTITER PLATE LUMINOMETER ML2200. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 K920888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date March 19, 1992
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 24
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K920888.
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
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FLUOROSCAN NEONATAL
K950415 · Isolab, Inc. · Sep 1995
OPUS MAGNUM ANALYZER
K926131 · Pb Diagnostic Systems, Inc. · Jun 1993
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991
DELFIA PLATE FLUOROMETER 1232
K895240 · Pharmacia, Inc. · Oct 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · Pb Diagnostic Systems, Inc. · Aug 1989