Cleared Traditional

K873479 - COL. CNA 5% SB/MACCONKEY AGAR BIPLATE #...

K873479 is the FDA 510(k) clearance for COL. CNA 5% SB/MACCONKEY AGAR BIPLATE #... by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K873479 · Lakewood Biochemical Co., Inc. · Microbiology device
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Oct 1987
Decision
42d
Days
Class 1
Risk

K873479 is an FDA 510(k) clearance for the COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206. 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 8, 1987 after a review of 42 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 K873479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date October 08, 1987
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
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 K873479.
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050
K874345 · Lakewood Biochemical Co., Inc. · Nov 1987
MICRO CULTURE MEDIA P3528, P3137, P3149, P3139
K873951 · Lakewood Biochemical Co., Inc. · Oct 1987
PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323
K873975 · Lakewood Biochemical Co., Inc. · Oct 1987
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)
K873827 · Lakewood Biochemical Co., Inc. · Oct 1987
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038
K873412 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412
K873323 · Lakewood Biochemical Co., Inc. · Oct 1987