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 Assay, Glycosylated Hemoglobin
510(k) Number K860572
Device Name GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
Applicant
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number864.7470
Classification Product Code
LCP  
Date Received02/14/1986
Decision Date 05/16/1986
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
-
-