Cleared Traditional

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT

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

About This 510(k) Submission

K874544 is an FDA 510(k) clearance for the SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT, a Test, Leukocyte Typing (Class I — General Controls, product code LGO), submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on August 12, 1988, 283 days after receiving the submission on November 3, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K874544 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1987
Decision Date August 12, 1988
Days to Decision 283 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LGO — Test, Leukocyte Typing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7675