Cleared Traditional

K874544 - SNAP CAMPYLOBACTER CULTURE IDENT DIAGNO...

K874544 is the FDA 510(k) clearance for SNAP CAMPYLOBACTER CULTURE IDENT DIAGNO... by Molecular Biosystems, Inc.. It is a Class 1 Microbiology device (product code LGO) cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K874544 · Molecular Biosystems, Inc. · Microbiology device
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Aug 1988
Decision
283d
Days
Class 1
Risk

K874544 is an FDA 510(k) clearance for the SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT. Classified as Test, Leukocyte Typing (product code LGO), Class I - General Controls.

Submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on August 12, 1988 after a review of 283 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.7675 - 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 K874544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1987
Decision Date August 12, 1988
Days to Decision 283 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 102d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGO Test, Leukocyte Typing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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 - LGO Test, Leukocyte Typing

Devices cleared under the same product code (LGO) and FDA review panel - the closest regulatory comparables to K874544.
PLATELIA TOXO IGG KIT
K894947 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
HLA CONTROL SERA
K791118 · Calbiochem-Behring Corp. · Aug 1979
LYMPHOCYTE TYPING, NEGATIVE CONTROL
K761008 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
K761009 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977