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 Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
510(k) Number K930208
Device Name CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
Applicant
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL J MURACA
Correspondent
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL J MURACA
Regulation Number862.3240
Classification Product Code
DLI  
Date Received01/15/1993
Decision Date 04/20/1993
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
-
-