Cleared Traditional

CHLAMYDOSPORE AGAR (K800818) - FDA 510(k) Clearance

Class I Microbiology device.

K800818 · Isle Media and Sterile Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 145
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K800818.
DNASE TEST AGAR
K881486 · Acumedia Manufacturers, Inc. · Apr 1988
FLO AGAR
K881540 · Acumedia Manufacturers, Inc. · Apr 1988
PHENOL RED BROTH BASE
K881551 · Acumedia Manufacturers, Inc. · Apr 1988
RUSSELL DOUBLE SUGAR AGAR
K881553 · Acumedia Manufacturers, Inc. · Apr 1988
UREA AGAR BASE
K881559 · Acumedia Manufacturers, Inc. · Apr 1988
UREA BROTH
K881560 · Acumedia Manufacturers, Inc. · Apr 1988