PROLACTIN (LACTOGEN) TEST SYSTEM— 510(k) K901673

Name: FDA 510(k) clearance K901673
Creator: U.S. Food and Drug Administration
Published: 1990-06-12

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K901673 for PROLACTIN (LACTOGEN) TEST SYSTEM, Substantially Equivalent on 1990-06-12. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1990-04-10
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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