Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Semen Analysis Device
510(k) Number K021746
FOIA Releasable 510(k) K021746
Device Name SQA V, SPERM QUALITY ANALYZER
Applicant
Medical Electronic Systems, LLC
269 S. Beverly Dr.
#472
Beverly Hills,  CA  90212
Applicant Contact ERICA B AMMIRATI
Correspondent
Medical Electronic Systems, LLC
269 S. Beverly Dr.
#472
Beverly Hills,  CA  90212
Correspondent Contact ERICA B AMMIRATI
Regulation Number864.5220
Classification Product Code
POV  
Date Received05/28/2002
Decision Date 09/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-