Cleared Traditional

K834122 - CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX

K834122 is the FDA 510(k) clearance for CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX by Bartels Immunodiagnostic Supplies, Inc.. It is a Class 1 Microbiology device (product code KIT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K834122 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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Feb 1984
Decision
76d
Days
Class 1
Risk

K834122 is an FDA 510(k) clearance for the CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K834122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date February 13, 1984
Days to Decision 76 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
26d faster than avg
Panel avg: 102d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 304
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K834122.
DEAE-DEXTRAN IN PBS
K834116 · Bartels Immunodiagnostic Supplies, Inc. · Apr 1984
TISSUE CULTURE REFEEDING MEDIUM
K834113 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
PBS W/MG+2 & CA+2
K834136 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM
K833389 · Sigma Chemical Co. · Nov 1983
TYRODE'S SALT SOLUTION W/SODIUM BICAR
K833390 · Sigma Chemical Co. · Nov 1983
LACTALBUMIN HYDROLYSATE MED. W/HANKS
K833391 · Sigma Chemical Co. · Nov 1983