Cleared Traditional

ELECSYS PROLACTIN ASSAY

K964748 · Boehringer Mannheim Corp. · Chemistry
Jan 1997
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K964748 is an FDA 510(k) clearance for the ELECSYS PROLACTIN ASSAY, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 21, 1997, 56 days after receiving the submission on November 26, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K964748 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1996
Decision Date January 21, 1997
Days to Decision 56 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

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