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 System, Test, Systemic Lupus Erythematosus
510(k) Number K800605
Device Name ANA LATEX SLIDE TEST
Applicant
Biologics Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biologics Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5820
Classification Product Code
DHC  
Date Received03/17/1980
Decision Date 04/02/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-