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 Antiserum, Positive And Negative Febrile Antigen Control Serum
510(k) Number K885113
Device Name IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
Applicant
Investigacion Farmaceutica S.A. DE C.V.
Calle 13-E # 5 Civac
Jiutepec, Morelos
Mexico,  MX
Applicant Contact SMITHERS HOGG
Correspondent
Investigacion Farmaceutica S.A. DE C.V.
Calle 13-E # 5 Civac
Jiutepec, Morelos
Mexico,  MX
Correspondent Contact SMITHERS HOGG
Regulation Number866.3085
Classification Product Code
GSN  
Date Received12/12/1988
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-