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, acetaminophen
510(k) Number K000494
Device Name SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Applicant Contact GAIL LEFEBVRE
Correspondent
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Correspondent Contact GAIL LEFEBVRE
Regulation Number862.3030
Classification Product Code
LDP  
Date Received02/15/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-