Cleared Traditional

MYCOPLASMELISA TEST KIT (K823804) - FDA 510(k) Clearance

Class I Microbiology device.

K823804 · M.A. Bioproducts · Microbiology device
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May 1983
Decision
159d
Days
Class 1
Risk

K823804 is an FDA 510(k) clearance for the MYCOPLASMELISA TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by M.A. Bioproducts (Walker, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 159 days - an extended review cycle.

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 M.A. Bioproducts devices

Submission Details

510(k) Number K823804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1982
Decision Date May 25, 1983
Days to Decision 159 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 102d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJZ Enzyme Linked Immunoabsorbent Assay, 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.