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 Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K852867
Device Name HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
Applicant
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Applicant Contact ANDREW J ESTRADA
Correspondent
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Correspondent Contact ANDREW J ESTRADA
Regulation Number862.1030
Classification Product Code
CKA  
Date Received07/08/1985
Decision Date 08/29/1985
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
-
-