• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name calibrator, multi-analyte mixture
510(k) Number K981305
Device Name OLYMPUS SERUM PROTEIN MULTICALIBRATOR
Original Applicant
OLYMPUS AMERICA, INC.
two corporate center dr.
melville,  NY  11747 -3157
Original Contact laura storms-tyler
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/10/1998
Decision Date 05/07/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-