Cleared Traditional

K870593 - T9000 TSB 10ML

K870593 is the FDA 510(k) clearance for T9000 TSB 10ML by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K870593 · Lakewood Biochemical Co., Inc. · Microbiology device
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Mar 1987
Decision
48d
Days
Class 1
Risk

K870593 is an FDA 510(k) clearance for the T9000 TSB 10ML. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on March 30, 1987 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Lakewood Biochemical Co., Inc. devices

Submission Details

510(k) Number K870593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date March 30, 1987
Days to Decision 48 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
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K870593.
T2500 FLUID THIO
K870799 · Lakewood Biochemical Co., Inc. · Mar 1987
T2570 THIO W/O IND W/O DEXTROSE
K870800 · Lakewood Biochemical Co., Inc. · Mar 1987
T4013 TSB 5ML
K870592 · Lakewood Biochemical Co., Inc. · Mar 1987
T4012 TSB 2ML
K870595 · Lakewood Biochemical Co., Inc. · Mar 1987
OXOID SIGNAL BLOOD CULTURE SYSTEM
K862946 · Oxoid U.S.A., Inc. · Nov 1986
CHARCOAL AGAR BASE
K861480 · Gibco Laboratories Life Technologies, Inc. · May 1986