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 Paraquat Assay
510(k) Number K843732
Device Name API UNISCEPT MIC
Applicant
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Applicant Contact SUSAN D TIEDY
Correspondent
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Correspondent Contact SUSAN D TIEDY
Classification Product Code
LTD  
Date Received09/24/1984
Decision Date 10/24/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-