Cleared Traditional

RADIOIMMUNOASSAY TEST SYSTEM PRL

K830412 · Monobind · Chemistry
Apr 1983
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K830412 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY TEST SYSTEM PRL, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 56 days after receiving the submission on February 8, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K830412 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1983
Decision Date April 05, 1983
Days to Decision 56 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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