Cleared Traditional

K834115 - CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT

K834115 is an FDA 510(k) clearance for CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Microbiology device with product code JSK cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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

FDA 510(k) Submission Details - K834115

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

JSK Device Classification - Class 1, General Controls

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.

Regulatory Peers - JSK Supplement, Culture Media

All 65
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K834115.
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · Oxoid U.S.A., Inc. · May 1984
TINSDALE ENRICHMENT
K834066 · Remel Co. · Jan 1984
LACTOSE
K833210 · Acumedia Manufacturers, Inc. · Oct 1983
CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW
K833018 · Gibco Laboratories Life Technologies, Inc. · Oct 1983