Cleared Traditional

K962499 - ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (FDA 510(k) Clearance)

Class I Immunology device.

K962499 · Bartels, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
71d
Days
Class 1
Risk

K962499 is an FDA 510(k) clearance for the ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER. Classified as Fluorometer (product code JZT), Class I - General Controls.

Submitted by Bartels, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4520 - the FDA immunology device 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 Bartels, Inc. devices

Submission Details

510(k) Number K962499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date September 05, 1996
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZT Fluorometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4520
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.