Cleared Traditional

K874537 - KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR

K874537 is an FDA 510(k) clearance for KLIGLER IRON AGAR AND TRIPLE SUGAR IRON..., manufactured by Lakewood Biochemical Co., Inc.. The device is a Class 1 Microbiology device with product code JSE cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K874537 · Lakewood Biochemical Co., Inc. · Microbiology device
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Nov 1987
Decision
17d
Days
Class 1
Risk

K874537 is an FDA 510(k) clearance for the KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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

FDA 510(k) Submission Details - K874537

510(k) Number K874537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1987
Decision Date November 20, 1987
Days to Decision 17 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
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

JSE Device Classification - Class 1, General Controls

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 43
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K874537.
X-ACT LDC/IND
K883996 · Pro-Lab, Inc. · Oct 1988
MRVP BROTH
K880116 · Hardy Media · Mar 1988
MIL MEDIUM
K880133 · Hardy Media · Mar 1988
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K871096 · bioMerieux, Inc. · Apr 1987
MICRODILUTION IDENTIFICATION PANELS
K864674 · American Micro Scan · Jan 1987
BIOTIS LITMUS MILK
K862393 · Otisville Biotech, Inc. · Jul 1986