Cleared Traditional

K910833 - COLOR VUE TM- MYCOPLASMA PNEUMONIAE

K910833 is an FDA 510(k) clearance for COLOR VUE TM- MYCOPLASMA PNEUMONIAE, manufactured by Seradyn, Inc.. The device is a Class 1 Microbiology device with product code GSA cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K910833 · Seradyn, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K910833

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

GSA Device Classification - Class 1, General Controls

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.