Cleared Traditional

K884105 - AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
(FDA 510(k) Clearance)

K884105 · Amersham Corp. · Chemistry

Nov 1988

Decision

48d

Days

Class 1

Risk

K884105 is an FDA 510(k) clearance for the AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT). This device is classified as a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP).

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 16, 1988, 48 days after receiving the submission on September 29, 1988.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number	K884105 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 1988
Decision Date	November 16, 1988
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—