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 Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K940272
Device Name ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
Applicant
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Applicant Contact DEAN P BONDERMAN, PH.D.
Correspondent
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Correspondent Contact DEAN P BONDERMAN, PH.D.
Regulation Number862.1660
Classification Product Code
JJX  
Date Received01/12/1994
Decision Date 04/20/1994
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
-
-