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 Radioimmunoassay, Cyclic Amp
510(k) Number K811273
Device Name CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1230
Classification Product Code
CHO  
Date Received05/07/1981
Decision Date 05/27/1981
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
-
-