Cleared Traditional

K854094 - IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
(FDA 510(k) Clearance)

K854094 · Immuchem Corp. · Chemistry

Feb 1986

Decision

144d

Days

Class 1

Risk

K854094 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS. This device is classified as a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS).

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on February 28, 1986, 144 days after receiving the submission on October 7, 1985.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number	K854094 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1985
Decision Date	February 28, 1986
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—