Cleared Traditional

K871264 - CARIESCREEN LB

K871264 is an FDA 510(k) clearance for CARIESCREEN LB, manufactured by Apo Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K871264 · Apo Diagnostics, Inc. · Microbiology device
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May 1987
Decision
37d
Days
Class 1
Risk

K871264 is an FDA 510(k) clearance for the CARIESCREEN LB. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Apo Diagnostics, Inc. (Ontario, Canada, CA). The FDA issued a Cleared decision on May 7, 1987 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Apo Diagnostics, Inc. devices

FDA 510(k) Submission Details - K871264

510(k) Number K871264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date May 07, 1987
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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.

Regulatory Peers - JSJ Culture Media, Selective And Non-differential

All 272
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