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, vanilmandelic, diazo, p-nitroaniline/vanillin
510(k) Number K861962
Device Name VANILMANDELIC ACID (VMA) REAGENT SET
Applicant
STERLING DIAGNOSTICS, INC.
34210 DEQUINDRE RD.
STERLING HEIGHTS,  MI  48077
Applicant Contact DAVID L CALLENDER
Correspondent
STERLING DIAGNOSTICS, INC.
34210 DEQUINDRE RD.
STERLING HEIGHTS,  MI  48077
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1795
Classification Product Code
CDF  
Date Received05/20/1986
Decision Date 07/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-