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, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
510(k) Number K931523
Device Name QUANTIMETRIX C-CLEAR(TM)
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250 -6703
Applicant Contact HIMAWAN SUTISNA
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250 -6703
Correspondent Contact HIMAWAN SUTISNA
Regulation Number862.1095
Classification Product Code
JMA  
Date Received03/26/1993
Decision Date 06/25/1993
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
-
-