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 Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K002350
Device Name REFACTO LABORATORY STANDARD
Applicant
The Genetics Institute
87 Cambridge Park Dr.
Cambridge,  MA  02140 -2387
Applicant Contact MARYANN KRANE
Correspondent
The Genetics Institute
87 Cambridge Park Dr.
Cambridge,  MA  02140 -2387
Correspondent Contact MARYANN KRANE
Regulation Number864.7290
Classification Product Code
GGP  
Date Received08/02/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-