AMERLEX HUMAN PLACENTAL LACTOGEN— 510(k) K840588

Name: FDA 510(k) clearance K840588
Creator: U.S. Food and Drug Administration
Published: 1984-04-04

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K840588 for AMERLEX HUMAN PLACENTAL LACTOGEN, Substantially Equivalent on 1984-04-04. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code JMF
Device class: Class 2
Regulation: 21 CFR 862.1585
Advisory panel: Clinical Chemistry
Date received: 1984-02-09
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K811370 — NATAL-TEC HPL1981-05-29
K802454 — GESTE FOLLOW KIT DETERM. OF HPL1980-11-12

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K912766 — AMERLITE CK-MB ASSAY1991-07-17
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