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 Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K894761
Device Name TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact MARTINIS, PHD
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact MARTINIS, PHD
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received07/27/1989
Decision Date 09/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-