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 Diazo Colorimetry, Bilirubin
510(k) Number K981632
Device Name ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact LUANN OCHS
Correspondent
Roche Diagnostics/Boehringer Mannheim GmbH
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact LUANN OCHS
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
MQM  
Date Received05/08/1998
Decision Date 06/15/1998
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
-
-