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 Colorimetry, Cholinesterase
510(k) Number K862168
Device Name RAICHEM CHOLINESTERASE REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.3240
Classification Product Code
DIH  
Date Received06/09/1986
Decision Date 06/27/1986
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
-
-