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 L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
510(k) Number K844965
Device Name LEUCINE AMINOPEPTIDASE REAGENT
Applicant
Alladin Diagnostic, Inc.
84 Bayard Ln.
Princeton,  NJ  08540
Applicant Contact ELIOT WOODBRIDGE
Correspondent
Alladin Diagnostic, Inc.
84 Bayard Ln.
Princeton,  NJ  08540
Correspondent Contact ELIOT WOODBRIDGE
Regulation Number862.1460
Classification Product Code
JGG  
Date Received12/24/1984
Decision Date 03/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-