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 Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K831419
Device Name RAICHEM LDH-P REAGENT W/SEPARATE START-
Applicant
Reagents Applications, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Reagents Applications, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received05/03/1983
Decision Date 06/16/1983
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
-
-