QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM— 510(k) K991395

Name: FDA 510(k) clearance K991395
Creator: U.S. Food and Drug Administration
Published: 2000-02-15

Substantially Equivalent

Advanced Reproductive Technologies

FDA 510(k) clearance K991395 for QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM, Substantially Equivalent on 2000-02-15. Applicant: Advanced Reproductive Technologies. Device class: 2.

Clearance details

Applicant: Advanced Reproductive Technologies
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 1999-04-21
Decision date: 2000-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.