SQA, SPERM QUALITY ANALYZER— 510(k) K012352

Name: FDA 510(k) clearance K012352
Creator: U.S. Food and Drug Administration
Published: 2001-09-21

Substantially Equivalent

Medical Electronic Systems, LLC

FDA 510(k) clearance K012352 for SQA, SPERM QUALITY ANALYZER, Substantially Equivalent on 2001-09-21. Applicant: Medical Electronic Systems, LLC. Device class: 2.

Clearance details

Applicant: Medical Electronic Systems, LLC
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2001-07-25
Decision date: 2001-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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