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 Carbol Fuchsin
510(k) Number K890148
Device Name ATS TB RAPID STAIN SET PRODUCT #034-45
Applicant
Alpha-Tec Systems, Inc.
P.O. Box 17196
Irvine,  CA  92713
Applicant Contact LAURIE A WILLIAMS
Correspondent
Alpha-Tec Systems, Inc.
P.O. Box 17196
Irvine,  CA  92713
Correspondent Contact LAURIE A WILLIAMS
Regulation Number864.1850
Classification Product Code
ICL  
Date Received01/13/1989
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-