Cleared Traditional

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)

K883878 · Amersham Corp. · Chemistry
Nov 1988
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K883878 is an FDA 510(k) clearance for the AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144), a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 1, 1988, 49 days after receiving the submission on September 13, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K883878 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1988
Decision Date November 01, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1625

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