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 Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K941313
Device Name STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact ALBERT BLANCE
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact ALBERT BLANCE
Regulation Number862.1050
Classification Product Code
CJE  
Date Received03/18/1994
Decision Date 05/17/1994
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
-
-