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 Drug Mixture Control Materials
510(k) Number K874757
Device Name STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
Applicant
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Applicant Contact KAREN H DARCY
Correspondent
Baxter Healthcare Corp
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact KAREN H DARCY
Regulation Number862.3280
Classification Product Code
DIF  
Date Received11/18/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-