Cleared Traditional

PROLACTIN (PRL) HORMONE MICROPLATE ELISA

K971921 · Monobind · Chemistry
Jun 1997
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K971921 is an FDA 510(k) clearance for the PROLACTIN (PRL) HORMONE MICROPLATE ELISA, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on June 24, 1997, 32 days after receiving the submission on May 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K971921 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1997
Decision Date June 24, 1997
Days to Decision 32 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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