Cleared Traditional

K873228 - LEVINE EOSIN METHYLENE BLUE AGAR (LEMB)...

K873228 is the FDA 510(k) clearance for LEVINE EOSIN METHYLENE BLUE AGAR (LEMB)... by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K873228 · Lakewood Biochemical Co., Inc. · Microbiology device
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Sep 1987
Decision
40d
Days
Class 1
Risk

K873228 is an FDA 510(k) clearance for the LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507. 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 September 23, 1987 after a review of 40 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 K873228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date September 23, 1987
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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 K873228.
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309
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K873227 · Lakewood Biochemical Co., Inc. · Sep 1987
MACCONKEY AGAR - PRODUCT #P1606
K873055 · Lakewood Biochemical Co., Inc. · Aug 1987
SORBITOL MACCONKEY AGAR NO. 3 CM 813
K872956 · Oxoid U.S.A., Inc. · Aug 1987
MACCONKEY W/SORBITOL
K872188 · Remel Co. · Jun 1987