Cleared Traditional

K874544 - SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT

K874544 is an FDA 510(k) clearance for SNAP CAMPYLOBACTER CULTURE IDENT DIAGNO..., manufactured by Molecular Biosystems, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K874544

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.

LGO Device Classification - Class 1, General Controls

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