Cleared Traditional

RIA KIT, PROLACTIN

K790003 · Cis Radiopharmaceuticals, Inc. · Chemistry
Mar 1979
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K790003 is an FDA 510(k) clearance for the RIA KIT, PROLACTIN, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1979, 69 days after receiving the submission on January 2, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K790003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1979
Decision Date March 12, 1979
Days to Decision 69 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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