Cleared Traditional

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL

K883726 · Immuchem Corp. · Chemistry
Dec 1988
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K883726 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on December 15, 1988, 106 days after receiving the submission on August 31, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K883726 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1988
Decision Date December 15, 1988
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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