Cleared Traditional

K953710 - ELX808 AUTOMATED MICROPLATE READERS

K953710 is the FDA 510(k) clearance for ELX808 AUTOMATED MICROPLATE READERS by Bio-Tek Instruments, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K953710 · Bio-Tek Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
77d
Days
Class 1
Risk

K953710 is an FDA 510(k) clearance for the ELX808 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 October 25, 1995 after a review of 77 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 K953710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1995
Decision Date October 25, 1995
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 K953710.
ELX800UV
K953572 · Bio-Tek Instruments, Inc. · Oct 1995
BILI-METER
K953005 · Olympic Medical Corp. · Sep 1995
5STRATEC SL 300 LIA-MAT
K950029 · Nichols Institute Diagnostics · Aug 1995
ELX800 AND EL800 AUTOMATED MICROPLATE READERS
K950104 · Bio-Tek Instruments, Inc. · Mar 1995
CERES 900C & CERES UV900C
K942923 · Bio-Tek Instruments, Inc. · Feb 1995
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · Instrumentation Laboratory CO · Nov 1994