Cleared Traditional

K934798 - PATHODX CYTOMEGALOVIRUS

K934798 is an FDA 510(k) clearance for PATHODX CYTOMEGALOVIRUS, manufactured by Diagnostic Products Corp.. The device is a Class 2 Microbiology device with product code LIN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K934798 · Diagnostic Products Corp. · Microbiology device
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Mar 1994
Decision
169d
Days
Class 2
Risk

K934798 is an FDA 510(k) clearance for the PATHODX CYTOMEGALOVIRUS. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 169 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K934798

510(k) Number K934798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date March 25, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 102d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIN Device Classification - Class 2, Special Controls

Product Code LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 14
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K934798.
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