Cleared Traditional

DELFIA(R) HGH KIT

K930484 · Wallac OY · Chemistry
May 1993
Decision
102d
Days
Class 1
Risk

About This 510(k) Submission

K930484 is an FDA 510(k) clearance for the DELFIA(R) HGH KIT, a Radioimmunoassay, Human Growth Hormone (Class I — General Controls, product code CFL), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on May 11, 1993, 102 days after receiving the submission on January 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K930484 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1993
Decision Date May 11, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFL — Radioimmunoassay, Human Growth Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1370

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