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 Container, Specimen, Sterile
510(k) Number K900983
Device Name TRI-TECH URINE SPECIMEN KIT
Applicant
Tri-Tech, Inc.
8904 Paddock Ln.
Potomac,  MD  20854
Applicant Contact BERNARD L KONOPKO
Correspondent
Tri-Tech, Inc.
8904 Paddock Ln.
Potomac,  MD  20854
Correspondent Contact BERNARD L KONOPKO
Regulation Number864.3250
Classification Product Code
FMH  
Date Received03/02/1990
Decision Date 09/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-