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 Antisera, Latex Agglutination, Cryptococcus Neoformans
510(k) Number K930418
Device Name CRYPTO-LEX SYSTEM
Applicant
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Applicant Contact BRUCE A CLINTON
Correspondent
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Correspondent Contact BRUCE A CLINTON
Regulation Number866.3165
Classification Product Code
GMD  
Date Received01/26/1993
Decision Date 02/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-