Cleared Traditional

K800818 - CHLAMYDOSPORE AGAR

K800818 is the FDA 510(k) clearance for CHLAMYDOSPORE AGAR by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800818 · Isle Media and Sterile Products, Inc. · Microbiology device
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Apr 1980
Decision
13d
Days
Class 1
Risk

K800818 is an FDA 510(k) clearance for the CHLAMYDOSPORE AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 13 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K800818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1980
Decision Date April 24, 1980
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
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 - JSH Culture Media, Non-selective And Differential

All 101
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K800818.
THIOGLYCOLLATE GELATIN MEDIUM
K811335 · Acumedia Manufacturers, Inc. · May 1981
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LACTOSE BROTH
K811130 · Acumedia Manufacturers, Inc. · May 1981
DECARBOXYLASE BROTH BASE WITH OR WITH-
K792421 · Isle Media and Sterile Products, Inc. · Dec 1979
VOGEL-JOHNSON AGAR
K792542 · Isle Media and Sterile Products, Inc. · Dec 1979
LYSINE IRON AGAR
K792544 · Isle Media and Sterile Products, Inc. · Dec 1979