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 Colorimetry, Acetaminophen
510(k) Number K821969
Device Name ACETAMINOPHEN STAT-PAK REAGENT SET
Applicant
Clin Tech Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clin Tech Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3030
Classification Product Code
LDP  
Date Received07/01/1982
Decision Date 07/16/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-