Cleared Traditional

K792484 - TIPSEP-T3U TRIIODOTHYRONINE UPTAKE

K792484 is an FDA 510(k) clearance for TIPSEP-T3U TRIIODOTHYRONINE UPTAKE, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code KHQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792484 · Nuclear Diagnostics, Inc. · Toxicology device
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Dec 1979
Decision
24d
Days
Class 2
Risk

K792484 is an FDA 510(k) clearance for the TIPSEP-T3U TRIIODOTHYRONINE UPTAKE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1715 - the FDA toxicology 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 Nuclear Diagnostics, Inc. devices

FDA 510(k) Submission Details - K792484

510(k) Number K792484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date December 27, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - KHQ Radioassay, Triiodothyronine Uptake

All 73
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K792484.
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
IMMUCHEM COVALENT COAT BINDING
K791662 · Immuchem Corp. · Sep 1979
T-3 UPTAKE (MAA) KIT
K790461 · Amersham Corp. · May 1979
T3 UPTAKE KIT
K790417 · E. R. Squibb & Sons, Inc. · Apr 1979