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 Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K922343
Device Name TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT
Applicant
Tri-Tech, Inc.
5108 Revere Rd.
Durham,  NC  27713
Applicant Contact WENDIE WALKER
Correspondent
Tri-Tech, Inc.
5108 Revere Rd.
Durham,  NC  27713
Correspondent Contact WENDIE WALKER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/19/1992
Decision Date 02/17/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-