Cleared Traditional

K941175 - ACCESS PROLACTIN (FDA 510(k) Clearance)

K941175 · Bio-Rad Laboratories, Inc. · Chemistry device

Jun 1994

Decision

80d

Days

Class 1

Risk

K941175 is an FDA 510(k) clearance for the ACCESS PROLACTIN. This device is classified as 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 June 2, 1994, 80 days after receiving the submission on March 14, 1994.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number	K941175 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 14, 1994
Decision Date	June 02, 1994
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

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