Cleared Traditional

K950104 - ELX800 AND EL800 AUTOMATED MICROPLATE R...

K950104 is the FDA 510(k) clearance for ELX800 AND EL800 AUTOMATED MICROPLATE R... by Bio-Tek Instruments, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K950104 · Bio-Tek Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Mar 1995
Decision
69d
Days
Class 1
Risk

K950104 is an FDA 510(k) clearance for the ELX800 AND EL800 AUTOMATED MICROPLATE READERS. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 69 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K950104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1995
Decision Date March 21, 1995
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 140
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K950104.
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