Cleared Traditional

SEROFAST (K903958) - FDA 510(k) Clearance

Class I Microbiology device.

K903958 · Intl. Mycoplasma/Mdc Assoc. · Microbiology device
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Dec 1990
Decision
115d
Days
Class 1
Risk

K903958 is an FDA 510(k) clearance for the SEROFAST. Classified as Antisera, All Mycoplasma Spp. (product code GSA), Class I - General Controls.

Submitted by Intl. Mycoplasma/Mdc Assoc. (Manchester, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 115 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 Intl. Mycoplasma/Mdc Assoc. devices

Submission Details

510(k) Number K903958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 21, 1990
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
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.