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 Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K982281
Device Name SERAQUEST RUBELLA IGM
Applicant
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Applicant Contact ROBERT A CORT
Correspondent
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Correspondent Contact ROBERT A CORT
Regulation Number866.3510
Classification Product Code
LFX  
Date Received06/30/1998
Decision Date 10/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-