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, luteinizing hormone
510(k) Number K913938
Device Name OPUS(R) LH TEST SYSTEM
Applicant
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/03/1991
Decision Date 11/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-