Cleared Traditional

COLOR VUE TM- MYCOPLASMA PNEUMONIAE (K910833) - FDA 510(k) Clearance

Class I Microbiology device.

K910833 · Seradyn, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
117d
Days
Class 1
Risk

K910833 is an FDA 510(k) clearance for the COLOR VUE TM- MYCOPLASMA PNEUMONIAE. Classified as Antisera, All Mycoplasma Spp. (product code GSA), Class I - General Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

Submission Details

510(k) Number K910833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date June 24, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GSA Antisera, All Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
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.