Cleared Traditional

K873241 - BRAIN HEART INFUS AGAR W/5% SB PENICILL...

K873241 is the FDA 510(k) clearance for BRAIN HEART INFUS AGAR W/5% SB PENICILL... by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K873241 · Lakewood Biochemical Co., Inc. · Microbiology device
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Sep 1987
Decision
39d
Days
Class 1
Risk

K873241 is an FDA 510(k) clearance for the BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM. 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 September 22, 1987 after a review of 39 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 K873241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date September 22, 1987
Days to Decision 39 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
63d faster than avg
Panel avg: 102d · This submission: 39d
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 K873241.
BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450
K873238 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463
K873239 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T3285
K873240 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM
K873242 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP
K873244 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION AGAR III - PRODUCT #P3590
K873229 · Lakewood Biochemical Co., Inc. · Sep 1987