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 Mercuric Thiocyanate, Colorimetry, Chloride
510(k) Number K945408
Device Name 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
Applicant
Catachem, Inc.
P.O. Box 6216
70 Hawley Ave.
Bridgeport,  CT  06606
Applicant Contact LUIS P LEON
Correspondent
Catachem, Inc.
P.O. Box 6216
70 Hawley Ave.
Bridgeport,  CT  06606
Correspondent Contact LUIS P LEON
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received11/03/1994
Decision Date 02/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-