Cleared Traditional

K910740 - SLT MICROPLATE WASHER

K910740 is the FDA 510(k) clearance for SLT MICROPLATE WASHER by Tecan U.S., Ltd.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K910740 · Tecan U.S., Ltd. · Chemistry device
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Mar 1991
Decision
34d
Days
Class 1
Risk

K910740 is an FDA 510(k) clearance for the SLT MICROPLATE WASHER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on March 27, 1991 after a review of 34 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 Tecan U.S., Ltd. devices

Submission Details

510(k) Number K910740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date March 27, 1991
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K910740.
MICROTRAK MANAGER
K912959 · Syva Co. · Jul 1991
CHEM-LINK DATA BASE MANAGER
K912413 · Technicon Instruments Corp. · Jul 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
K911438 · Bio-Tek Instruments, Inc. · May 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · Gen-Probe, Inc. · Jan 1991
GEN-PROBE PAL LUMINOMETER
K903911 · Gen-Probe, Inc. · Oct 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934 · Gen-Probe, Inc. · Sep 1990