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 K884224
Device Name TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
Applicant
A-Kem, Inc.
P.O. Box 1589
82 Industrial E.
Clifton,  NJ  07015
Applicant Contact STEVEN LEE
Correspondent
A-Kem, Inc.
P.O. Box 1589
82 Industrial E.
Clifton,  NJ  07015
Correspondent Contact STEVEN LEE
Regulation Number862.1110
Classification Product Code
CIG  
Date Received10/06/1988
Decision Date 12/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-