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 K812242
Device Name CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
Applicant
CORDIS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CORDIS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/11/1981
Decision Date 09/09/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-