Cleared Traditional

K823010 - MICRO TRAK CHLAMYDIA TRACHOMATIS CULT

K823010 is the FDA 510(k) clearance for MICRO TRAK CHLAMYDIA TRACHOMATIS CULT by Syva Co.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K823010 · Syva Co. · Microbiology device
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Dec 1982
Decision
64d
Days
Class 1
Risk

K823010 is an FDA 510(k) clearance for the MICRO TRAK CHLAMYDIA TRACHOMATIS CULT. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syva Co. devices

Submission Details

510(k) Number K823010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1982
Decision Date December 15, 1982
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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.