Cleared Traditional

K873325 - SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE

K873325 is an FDA 510(k) clearance for SABOURAUD DEXTROSE SD EMMONS MOD. AGAR ..., manufactured by Lakewood Biochemical Co., Inc.. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K873325 · Lakewood Biochemical Co., Inc. · Microbiology device
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Oct 1987
Decision
45d
Days
Class 1
Risk

K873325 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE. 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

FDA 510(k) Submission Details - K873325

510(k) Number K873325 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.

JSG Device Classification - Class 1, General Controls

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 189
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K873325.
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K873483 · Lakewood Biochemical Co., Inc. · Oct 1987
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K873328 · Lakewood Biochemical Co., Inc. · Oct 1987
BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006
K873217 · Lakewood Biochemical Co., Inc. · Sep 1987
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K873219 · Lakewood Biochemical Co., Inc. · Sep 1987