Cleared Traditional

K954680 - ACCESS PROLACTIN ASSAY (MODIFICATION)
(FDA 510(k) Clearance)

K954680 · Bio-Rad Laboratories, Inc. · Chemistry

Oct 1995

Decision

18d

Days

Class 1

Risk

K954680 is an FDA 510(k) clearance for the ACCESS PROLACTIN ASSAY (MODIFICATION), a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 20, 1995, 18 days after receiving the submission on October 2, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number	K954680 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 1995
Decision Date	October 20, 1995
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF