Cleared Traditional

CAMPY-S AGAR (K821218) - FDA 510(k) Clearance

Class I Microbiology device.

K821218 · Isle Media and Sterile Products, Inc. · Microbiology device
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May 1982
Decision
17d
Days
Class 1
Risk

K821218 is an FDA 510(k) clearance for the CAMPY-S AGAR. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K821218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 14, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
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 306
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