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 Amyloclastic, Amylase
510(k) Number K833864
Device Name AMYLASE REAGENT SET-MODIFIED CARAWAY
Applicant
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterling Biochemical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1070
Classification Product Code
CJA  
Date Received11/07/1983
Decision Date 01/13/1984
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
-
-