Cleared Traditional

ANAEROBIC BLOOD AGAR (K812795) - FDA 510(k) Clearance

Class I Microbiology device.

K812795 · Isle Media and Sterile Products, Inc. · Microbiology device
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Oct 1981
Decision
14d
Days
Class 1
Risk

K812795 is an FDA 510(k) clearance for the ANAEROBIC BLOOD AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981 after a review of 14 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K812795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date October 20, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
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 208
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K812795.
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CASEIN PEPTONE, LOW VITAMIN
K881528 · Acumedia Manufacturers, Inc. · Apr 1988
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K881531 · Acumedia Manufacturers, Inc. · Apr 1988
BLOOD AGAR BASE W/LOW PH
K881532 · Acumedia Manufacturers, Inc. · Apr 1988