Cleared Traditional

K993812 - CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K

K993812 is an FDA 510(k) clearance for CVM TRANSPORT, manufactured by Hardy Diagnostics. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K993812 · Hardy Diagnostics · Microbiology device
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Dec 1999
Decision
41d
Days
Class 1
Risk

K993812 is an FDA 510(k) clearance for the CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL.... Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Diagnostics devices

FDA 510(k) Submission Details - K993812

510(k) Number K993812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1999
Decision Date December 21, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K993812.
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K970597 · Medical Packaging Corp. · Mar 1997
A.C.T. I
K965149 · Remel Co. · Jan 1997