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, Rheumatoid Factor
510(k) Number K853054
Device Name RF CARD TEST
Applicant
Preco, Inc.
9 Post Rd.
Oakland,  NJ  07436
Applicant Contact MARTIN GOULD
Correspondent
Preco, Inc.
9 Post Rd.
Oakland,  NJ  07436
Correspondent Contact MARTIN GOULD
Regulation Number866.5775
Classification Product Code
DHR  
Date Received07/19/1985
Decision Date 08/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-