HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI— 510(k) K983586

Name: FDA 510(k) clearance K983586
Creator: U.S. Food and Drug Administration
Published: 1999-02-18

Substantially Equivalent

Irvine Scientific Sales Co., Inc.

FDA 510(k) clearance K983586 for HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI, Substantially Equivalent on 1999-02-18. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.

Clearance details

Applicant: Irvine Scientific Sales Co., Inc.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 1998-10-13
Decision date: 1999-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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