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 System, Test, Low Density, Lipoprotein
510(k) Number K982848
Device Name COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact MARIA FEIJOO
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Code
JIT  
Date Received08/12/1998
Decision Date 10/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-