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 K863980
Device Name U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
Applicant
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Applicant Contact ROY E SPECK
Correspondent
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Correspondent Contact ROY E SPECK
Regulation Number862.1050
Classification Product Code
CJE  
Date Received10/14/1986
Decision Date 12/04/1986
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
-
-