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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT ANTI-DELTA EIA
Generic NameHEPATITIS DELTA SEROLOGICAL REAGENTS
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP850062
Supplement NumberS002
Date Received01/21/1997
Decision Date02/26/1997
Withdrawal Date03/22/2007
Product Code LQI 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE SPECIFICATIONS FOR THE CONJUGATE CONCENTRATE FROM A NEGATIVE CONTROL SAMPLE WITH A STANDARD RATION OF 0.90- 1.10, TO A NEGATIVE CONTROL MEAN O.D. OF 1.17 - 1.43
-
-