Cleared Traditional

K834115 - CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT (FDA 510(k) Clearance)

Class I Microbiology device.

K834115 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Mar 1984
Decision
115d
Days
Class 1
Risk

K834115 is an FDA 510(k) clearance for the CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K834115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date March 23, 1984
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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.