Cleared Traditional

K800187 - EMC-M-175, THYROXINE - 100 TUBES

K800187 is an FDA 510(k) clearance for EMC-M-175, manufactured by Endocrine-Metabolic Center. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800187 · Endocrine-Metabolic Center · Chemistry device
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Feb 1980
Decision
15d
Days
Class 2
Risk

K800187 is an FDA 510(k) clearance for the EMC-M-175, THYROXINE - 100 TUBES. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Endocrine-Metabolic Center (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Endocrine-Metabolic Center devices

FDA 510(k) Submission Details - K800187

510(k) Number K800187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1980
Decision Date February 13, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 94
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K800187.
ANALYTE T4-THYROXINE
K800385 · Technicon Instruments Corp. · Mar 1980
AMERLEX T-4 RIA KIT
K800300 · Amersham Corp. · Mar 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · Miles Laboratories, Inc. · Feb 1980
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · Nuclear Diagnostics, Inc. · Jan 1980
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · Abbott Laboratories · Nov 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791664 · Immuchem Corp. · Sep 1979