Cleared Traditional

K840338 - HAEMOPHILUS I.D. II TRIPLATE

K840338 is the FDA 510(k) clearance for HAEMOPHILUS I.D. II TRIPLATE by Remel Co.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K840338 · Remel Co. · Microbiology device
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Apr 1984
Decision
83d
Days
Class 1
Risk

K840338 is an FDA 510(k) clearance for the HAEMOPHILUS I.D. II TRIPLATE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 83 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 Remel Co. devices

Submission Details

510(k) Number K840338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date April 17, 1984
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
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 K840338.
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