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 Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
510(k) Number K851521
Device Name LD-1(IMMUNO) SEPARATION SET
Applicant
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL J SULLIVAN
Correspondent
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number862.1445
Classification Product Code
CEX  
Date Received04/15/1985
Decision Date 05/10/1985
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
-
-