Cleared Traditional

K791662 - IMMUCHEM COVALENT COAT BINDING

K791662 is the FDA 510(k) clearance for IMMUCHEM COVALENT COAT BINDING by Immuchem Corp.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791662 · Immuchem Corp. · Chemistry device
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Sep 1979
Decision
37d
Days
Class 2
Risk

K791662 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT BINDING. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Immuchem Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 K791662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 27, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 59
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K791662.
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · Miles Laboratories, Inc. · Feb 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · Micromedic Systems · Jan 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1980
T-3 UPTAKE (MAA) KIT
K790461 · Amersham Corp. · May 1979
T3 UPTAKE KIT
K790417 · E. R. Squibb & Sons, Inc. · Apr 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · Kallestad Laboratories, Inc. · Jan 1979