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 Photometric Method, Iron (Non-Heme)
510(k) Number K881104
Device Name PARAMAX IRON REAGENT
Applicant
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KRISTA SMALLEY
Correspondent
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KRISTA SMALLEY
Regulation Number862.1410
Classification Product Code
JIY  
Date Received03/15/1988
Decision Date 04/28/1988
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
-
-