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 radioassay, vitamin b12
510(k) Number K833247
Device Name QUANTAPHASE B-12-COBALMIN-FOLATE-
Applicant
BIO-RAD
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIO-RAD
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1810
Classification Product Code
CDD  
Date Received09/30/1983
Decision Date 10/19/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-