Cleared Traditional

K800980 - HEXTOEN ENTERIC AGAR

K800980 is the FDA 510(k) clearance for HEXTOEN ENTERIC AGAR by Quality Assurance Laboratory, Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K800980 · Quality Assurance Laboratory, Inc. · Microbiology device
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May 1980
Decision
30d
Days
Class 1
Risk

K800980 is an FDA 510(k) clearance for the HEXTOEN ENTERIC AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Quality Assurance Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 30 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 Quality Assurance Laboratory, Inc. devices

Submission Details

510(k) Number K800980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date May 23, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 202
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K800980.
PERFRINGENS AGAR BASE
K810929 · Oxoid U.S.A., Inc. · Apr 1981
SS AGAR (MODIFIED)
K810931 · Oxoid U.S.A., Inc. · Apr 1981
VOTEL-JOHNSON AGAR (MODIFIED)
K810933 · Oxoid U.S.A., Inc. · Apr 1981
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K800745 · Remel Co. · May 1980
BISMUTH SULFITE AGAR
K800157 · Isle Media and Sterile Products, Inc. · Feb 1980
CHOCOLATE TELLURITE AGAR
K792424 · Isle Media and Sterile Products, Inc. · Dec 1979