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 Calibrator, Multi-Analyte Mixture
510(k) Number K042243
Device Name MICROALBUMIN MULTI-CALIBRATOR SET
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, PRINCE EDWARD,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, PRINCE EDWARD,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/19/2004
Decision Date 10/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-