Cleared Traditional

K834066 - TINSDALE ENRICHMENT

K834066 is the FDA 510(k) clearance for TINSDALE ENRICHMENT by Remel Co.. It is a Class 1 Microbiology device (product code JSK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K834066 · Remel Co. · Microbiology device
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Jan 1984
Decision
40d
Days
Class 1
Risk

K834066 is an FDA 510(k) clearance for the TINSDALE ENRICHMENT. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 40 days - a notably fast clearance cycle.

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: 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 Remel Co. devices

Submission Details

510(k) Number K834066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date January 04, 1984
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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.

Regulatory Peers - JSK Supplement, Culture Media

All 56
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K834066.
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · Oxoid U.S.A., Inc. · May 1984
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
K834115 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
LACTOSE
K833210 · Acumedia Manufacturers, Inc. · Oct 1983
CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW
K833018 · Gibco Laboratories Life Technologies, Inc. · Oct 1983
CAMPYLOBACTER SELECTIVE SUPPLE-BLASER
K833019 · Gibco Laboratories Life Technologies, Inc. · Oct 1983