Cleared Traditional

DSL ACTIVE PROLACTIN IRMA

K960060 · Diagnostic Systems Laboratories, Inc. · Chemistry
Feb 1996
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K960060 is an FDA 510(k) clearance for the DSL ACTIVE PROLACTIN IRMA, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on February 29, 1996, 56 days after receiving the submission on January 4, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K960060 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1996
Decision Date February 29, 1996
Days to Decision 56 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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