Cleared Traditional

K873328 - SABOURAUD DEXTROSE - EMMONS AGAR PLATE ...

K873328 is the FDA 510(k) clearance for SABOURAUD DEXTROSE - EMMONS AGAR PLATE ... by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K873328 · Lakewood Biochemical Co., Inc. · Microbiology device
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Oct 1987
Decision
45d
Days
Class 1
Risk

K873328 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252. 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 October 2, 1987 after a review of 45 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 K873328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1987
Decision Date October 02, 1987
Days to Decision 45 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
57d faster than avg
Panel avg: 102d · This submission: 45d
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 K873328.
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K873483 · Lakewood Biochemical Co., Inc. · Oct 1987
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K873325 · Lakewood Biochemical Co., Inc. · Oct 1987
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K873217 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583
K873219 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003
K873220 · Lakewood Biochemical Co., Inc. · Sep 1987