Cleared Traditional

K791671 - DNASE TEST AGAR

K791671 is the FDA 510(k) clearance for DNASE TEST 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 34-day FDA review.

K791671 · Isle Media and Sterile Products, Inc. · Microbiology device
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Oct 1979
Decision
34d
Days
Class 1
Risk

K791671 is an FDA 510(k) clearance for the DNASE TEST 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 October 1, 1979 after a review of 34 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 K791671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1979
Decision Date October 01, 1979
Days to Decision 34 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
68d faster than avg
Panel avg: 102d · This submission: 34d
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 K791671.
PHENOL RED BROTH
K791941 · Isle Media and Sterile Products, Inc. · Oct 1979
NITRATE AGAR
K791944 · Isle Media and Sterile Products, Inc. · Oct 1979
OF BASAL MEDIUM
K791946 · Isle Media and Sterile Products, Inc. · Oct 1979
DNASE TEST AGAR W/METHYL GREEN
K791813 · Isle Media and Sterile Products, Inc. · Oct 1979
BILE ESCULIN AGAR
K791814 · Isle Media and Sterile Products, Inc. · Oct 1979
MIO MEDIUM (MOTILITY INDOLE ORNITHINE)
K791817 · Isle Media and Sterile Products, Inc. · Oct 1979