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 Manual Antimicrobial Susceptibility Test Systems
510(k) Number K991925
Device Name PASCO MIC AND MIC/ID PANELS
Applicant
Pasco Laboratories, Inc.
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033
Applicant Contact LINDA K DILLON
Correspondent
Pasco Laboratories, Inc.
12750 W. 42nd Ave.
Wheat Ridge,  CO  80033
Correspondent Contact LINDA K DILLON
Regulation Number866.1640
Classification Product Code
JWY  
Date Received06/08/1999
Decision Date 08/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-