Cleared Traditional

K883083 - MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM

K883083 is an FDA 510(k) clearance for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TE..., manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 1 Microbiology device with product code GSA cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K883083 · Medical Diagnostic Technologies, Inc. · Microbiology device
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Oct 1988
Decision
96d
Days
Class 1
Risk

K883083 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM. Classified as Antisera, All Mycoplasma Spp. (product code GSA), Class I - General Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 96 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K883083

510(k) Number K883083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1988
Decision Date October 25, 1988
Days to Decision 96 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
6d faster than avg
Panel avg: 102d · This submission: 96d
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.