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 Azo Dye, Calcium
510(k) Number K761029
Device Name AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
Applicant
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1145
Classification Product Code
CJY  
Date Received11/12/1976
Decision Date 11/30/1976
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
-
-