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 Drug Mixture Control Materials
510(k) Number K870586
Device Name TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
Applicant
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact DONNA L ANDERSON
Correspondent
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact DONNA L ANDERSON
Regulation Number862.3280
Classification Product Code
DIF  
Date Received02/11/1987
Decision Date 04/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-