Cleared Traditional

K811642 - EOSIN METHYLENE BLUE AGAR (LEVINE)

K811642 is the FDA 510(k) clearance for EOSIN METHYLENE BLUE AGAR (LEVINE) by Hardy Media. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811642 · Hardy Media · Microbiology device
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Jul 1981
Decision
23d
Days
Class 1
Risk

K811642 is an FDA 510(k) clearance for the EOSIN METHYLENE BLUE AGAR (LEVINE). Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 23 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 Hardy Media devices

Submission Details

510(k) Number K811642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1981
Decision Date July 02, 1981
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
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 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K811642.
EOSIN METHYLENE BLUE AGAR
K820552 · American Laboratory Supply, Inc. · Mar 1982
BILE ESCULIN AZIDE AGAR
K820553 · American Laboratory Supply, Inc. · Mar 1982
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · Hoffmann-La Roche, Inc. · Oct 1981
MACCONKEY AGAR
K811643 · Hardy Media · Jul 1981
HEKTOEN ENTERIC AGAR
K811644 · Hardy Media · Jul 1981
SALMONELLA-SHIGELLA AGAR
K811647 · Hardy Media · Jul 1981