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 Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K922340
Device Name ENCORE SS-B
Applicant
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Applicant Contact Gary Lehnus
Correspondent
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Correspondent Contact Gary Lehnus
Regulation Number866.5100
Classification Product Code
LLL  
Date Received05/19/1992
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-