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 K000887
Device Name DRX HBA1C
Applicant
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Applicant Contact JOEAL M BLATT
Correspondent
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Correspondent Contact JOEAL M BLATT
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/20/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-