• 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 | Inspections

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namehepatitis delta serological reagents
Generic Nameanti-delta (ria)
PMA NumberP850062
Supplement NumberS002
Date Received01/21/1997
Decision Date02/26/1997
Product Code
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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.