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 Enzyme Immunoassay, Phencyclidine
510(k) Number K000462
Device Name URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
Applicant
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Applicant Contact JUDY MCINNIS-BERGER
Correspondent
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Correspondent Contact JUDY MCINNIS-BERGER
Classification Product Code
LCM  
Date Received02/11/2000
Decision Date 04/06/2000
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-