Cleared Traditional

K800158 - AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD

K800158 is the FDA 510(k) clearance for AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800158 · Isle Media and Sterile Products, Inc. · Microbiology device
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Feb 1980
Decision
20d
Days
Class 1
Risk

K800158 is an FDA 510(k) clearance for the AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD. 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 February 13, 1980 after a review of 20 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 K800158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1980
Decision Date February 13, 1980
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
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 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K800158.
SMITH'S SYSTEMIC FUNGAL MEDIUM
K792715 · Meridian Diagnostics, Inc. · Mar 1980
CAMPYLOBACTER AGAR, CAT. NO. P2536
K800329 · Gibco Laboratories Life Technologies, Inc. · Mar 1980
STAPHYLOCOCCUS MED. 110
K800156 · Isle Media and Sterile Products, Inc. · Feb 1980
CAMPY THIO
K792676 · Remel Co. · Jan 1980
TRYPTIC SOY SXT AGAR W/SHEEP BLOOD
K792720 · Gibco Laboratories Life Technologies, Inc. · Jan 1980
TETRATHIONATE BROTH BASE
K792422 · Isle Media and Sterile Products, Inc. · Dec 1979