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 Antisera, Control For Nontreponemal Tests
510(k) Number K980638
Device Name ADI SYPHILIS RPR LIQUID CONTROLS
Applicant
Ampcor Diagnostics, Inc.
603 Heron Dr., Bldg. 3
Bridgeport,  NJ  08104
Applicant Contact RAYMOND MILLER
Correspondent
Ampcor Diagnostics, Inc.
603 Heron Dr., Bldg. 3
Bridgeport,  NJ  08104
Correspondent Contact RAYMOND MILLER
Regulation Number866.3820
Classification Product Code
GMP  
Date Received02/19/1998
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-