Cleared Traditional

K873412 - GRAM NEGATIVE (GN) BROTH

K873412 is the FDA 510(k) clearance for GRAM NEGATIVE (GN) BROTH by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K873412 · Lakewood Biochemical Co., Inc. · Microbiology device
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Oct 1987
Decision
43d
Days
Class 1
Risk

K873412 is an FDA 510(k) clearance for the GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038. Classified as Culture Media, Selective And Non-differential (product code JSJ), 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 866.2360 - 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 K873412 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 JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K873412.
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K873975 · Lakewood Biochemical Co., Inc. · Oct 1987
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K873479 · Lakewood Biochemical Co., Inc. · Oct 1987
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)
K873827 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412
K873323 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080
K873326 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330
K873327 · Lakewood Biochemical Co., Inc. · Oct 1987