Cleared Traditional

SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670) - FDA 510(k) Clearance

Class I Microbiology device.

K873670 · Molecular Biosystems, Inc. · Microbiology device
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Jun 1988
Decision
271d
Days
Class 1
Risk

K873670 is an FDA 510(k) clearance for the SNAP CAMPYLOBACTOR DIAGNOSTIC KIT. Classified as Dna-reagents, Campylobacter Spp. (product code LQO), Class I - General Controls.

Submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on June 8, 1988 after a review of 271 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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 Molecular Biosystems, Inc. devices

Submission Details

510(k) Number K873670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1987
Decision Date June 08, 1988
Days to Decision 271 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 102d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQO Dna-reagents, Campylobacter Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.