Cleared Traditional

K791663 - IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

K791663 is the FDA 510(k) clearance for IMMUCHEM COVALENT COAT SOLID PHASE ASSAY by Immuchem Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K791663 · Immuchem Corp. · Chemistry device
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Oct 1979
Decision
41d
Days
Class 2
Risk

K791663 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT SOLID PHASE ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Immuchem Corp. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - the FDA in vitro diagnostics and chemistry 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 Immuchem Corp. devices

Submission Details

510(k) Number K791663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date October 01, 1979
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 101
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K791663.
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