Cleared Traditional

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

K863860 · Hybritech, Inc. · Chemistry
Nov 1986
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K863860 is an FDA 510(k) clearance for the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1986, 49 days after receiving the submission on October 3, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K863860 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1986
Decision Date November 21, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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