Cleared Traditional

K830036 - NEONATAL NTSH RADIOIMMUNOASSAY SYS

K830036 is an FDA 510(k) clearance for NEONATAL NTSH RADIOIMMUNOASSAY SYS, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K830036 · Corning Medical & Scientific · Chemistry device
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Jan 1983
Decision
21d
Days
Class 2
Risk

K830036 is an FDA 510(k) clearance for the NEONATAL NTSH RADIOIMMUNOASSAY SYS. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Corning Medical & Scientific devices

FDA 510(k) Submission Details - K830036

510(k) Number K830036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date January 28, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 199
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K830036.
AUTOPAK NEONATAL TSH RIA KIT
K832462 · Micromedic Systems · Sep 1983
MAGIC TSH 125I RADIOIMMUNOASSAY
K832313 · Corning Medical & Scientific · Sep 1983
VENTREX ENZYME TSH KIT
K830928 · Ventrex Laboratories, Inc. · Apr 1983
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO
K823688 · Corning Medical & Scientific · Jan 1983
THYROID STIMULATING HORMONE
K822935 · Pcl-Ria, Inc. · Nov 1982
HISH EIA DIAGNOSTIC KIT
K822827 · Abbott Laboratories · Oct 1982