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 acid, uric, uricase (u.v.)
510(k) Number K770831
Device Name STATZYME URIC ACID REAGENT
Applicant
WORTHINGTON BIOCHEMICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WORTHINGTON BIOCHEMICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1775
Classification Product Code
CDO  
Date Received05/06/1977
Decision Date 07/11/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-