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 Antigens (Febrile), Agglutination, Brucella Spp.
510(k) Number K972394
Device Name VISTA ANTIGEN BRUCELLA ABORTUS
Applicant
Lee Laboratories, Inc.
1475 Hwy. 78, SW
Grayson,  GA  30221
Applicant Contact ROBIN C HART
Correspondent
Lee Laboratories, Inc.
1475 Hwy. 78, SW
Grayson,  GA  30221
Correspondent Contact ROBIN C HART
Regulation Number866.3085
Classification Product Code
GSO  
Date Received06/26/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-