Cleared Traditional

PHARMACIA DELFIA NEONATAL HTSH KIT

K905710 · Pharmacia, Inc. · Chemistry
Feb 1991
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K905710 is an FDA 510(k) clearance for the PHARMACIA DELFIA NEONATAL HTSH KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on February 21, 1991, 62 days after receiving the submission on December 21, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K905710 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1990
Decision Date February 21, 1991
Days to Decision 62 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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