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 Test, Leukocyte Alkaline Phosphatase
510(k) Number K896092
Device Name ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact TAKES, PHD
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact TAKES, PHD
Regulation Number864.7660
Classification Product Code
GHD  
Date Received10/19/1989
Decision Date 11/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-