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 K952337
Device Name ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Correspondent Contact CAROL L KRIEGER
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/19/1995
Decision Date 02/09/1996
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
Recalls CDRH Recalls
-
-