Cleared Traditional

K864241 - DNASE AGAR

K864241 is the FDA 510(k) clearance for DNASE AGAR by Mds Laboratories, Inc.. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864241 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 1
Risk

K864241 is an FDA 510(k) clearance for the DNASE AGAR. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mds Laboratories, Inc. devices

Submission Details

510(k) Number K864241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single Biochemical Test
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 - JSF Culture Media, Single Biochemical Test

All 58
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K864241.
NUTRIENT GELATIN
K880115 · Hardy Media · Mar 1988
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
K873828 · Lakewood Biochemical Co., Inc. · Oct 1987
TRYPTONE BROTH, 2%
K870641 · Hardy Media · Apr 1987
BIOTIS MOTILITY TEST MEDIUM
K862392 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K862396 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K862397 · Otisville Biotech, Inc. · Jul 1986