Cleared Traditional

HPROLACTIN KIT

K871542 · Immuchem Corp. · Chemistry
May 1987
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K871542 is an FDA 510(k) clearance for the HPROLACTIN KIT, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on May 14, 1987, 24 days after receiving the submission on April 20, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K871542 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1987
Decision Date May 14, 1987
Days to Decision 24 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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