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 Visual, Pregnancy Hcg, Prescription Use
510(k) Number K853258
Device Name BETA-HCG MICROTITER PREGNANCY TEST
Applicant
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Applicant Contact ROBERT L BUCK
Correspondent
Modern Diagnostics, Inc.
5859 Power Inn Rd.
Sacramento,  CA  95824
Correspondent Contact ROBERT L BUCK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/02/1985
Decision Date 10/01/1985
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
-
-