Cleared Traditional

K873411 - SIMMONS CITRATE MEDIUM SLANT

K873411 is the FDA 510(k) clearance for SIMMONS CITRATE MEDIUM SLANT by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K873411 · Lakewood Biochemical Co., Inc. · Microbiology device
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Oct 1987
Decision
43d
Days
Class 1
Risk

K873411 is an FDA 510(k) clearance for the SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 6, 1987 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 K873411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date October 06, 1987
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 101
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K873411.
UREA BROTH
K881560 · Acumedia Manufacturers, Inc. · Apr 1988
MOELLERS DECARBOXYLASE, BASE
K880121 · Hardy Media · Mar 1988
OF MEDIUM BASE
K880117 · Hardy Media · Mar 1988
LYSINE IRON AGAR (LIA) PRODUCT #T3046
K873703 · Lakewood Biochemical Co., Inc. · Oct 1987
MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053
K873704 · Lakewood Biochemical Co., Inc. · Oct 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987