Cleared Traditional

K870340 - Z2017

K870340 is the FDA 510(k) clearance for Z2017 by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K870340 · Lakewood Biochemical Co., Inc. · Microbiology device
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Feb 1987
Decision
16d
Days
Class 1
Risk

K870340 is an FDA 510(k) clearance for the Z2017, BEA/CNA 5%SB BIPLATE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on February 13, 1987 after a review of 16 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 K870340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date February 13, 1987
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K870340.
ANAEROBIC LKV BLOOD AGAR
K871088 · bioMerieux, Inc. · Apr 1987
BRILLIANT GREEN AGAR
K871094 · bioMerieux, Inc. · Apr 1987
P4802 BEA
K870339 · Lakewood Biochemical Co., Inc. · Feb 1987
P1012 BE AGAR
K870341 · Lakewood Biochemical Co., Inc. · Feb 1987
T1365 (BIRD SEED AGAR SLANT)
K870057 · Lakewood Biochemical Co., Inc. · Feb 1987
CANDIDA BROM CRESOL GREEN AGAR
K864077 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986