Cleared Traditional

K873221 - BRAIN HEART INFUSION AGAR W/5% SB - PRO...

K873221 is the FDA 510(k) clearance for BRAIN HEART INFUSION AGAR W/5% SB - PRO... by Lakewood Biochemical Co., Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K873221 · Lakewood Biochemical Co., Inc. · Microbiology device
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Sep 1987
Decision
40d
Days
Class 1
Risk

K873221 is an FDA 510(k) clearance for the BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409. Classified as Culture Media, Non-selective And Non-differential (product code JSG), 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 866.2300 - 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 K873221 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 JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K873221.
BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006
K873217 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583
K873219 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003
K873220 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION BROTH W/X AND V - #T4540
K873222 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004
K873235 · Lakewood Biochemical Co., Inc. · Sep 1987
BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904
K873236 · Lakewood Biochemical Co., Inc. · Sep 1987