Cleared Traditional

K904137 - UC IMU B

K904137 is an FDA 510(k) clearance for UC IMU B, manufactured by Eucardio Laboratory, Inc.. The device is a Class 2 Immunology device with product code DFC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K904137 · Eucardio Laboratory, Inc. · Immunology device
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Nov 1990
Decision
76d
Days
Class 2
Risk

K904137 is an FDA 510(k) clearance for the UC IMU B. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Eucardio Laboratory, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5600 - the FDA immunology 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 Eucardio Laboratory, Inc. devices

FDA 510(k) Submission Details - K904137

510(k) Number K904137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 21, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 105d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 Immunology devices follow this clearance model.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 39
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