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 Device, General Purpose, Microbiology, Diagnostic
510(k) Number K844442
Device Name RAPID DIAGNOSTIC KIT
Applicant
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Applicant Contact WARREN R SANBORN
Correspondent
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Correspondent Contact WARREN R SANBORN
Regulation Number866.2660
Classification Product Code
LIB  
Date Received11/16/1984
Decision Date 02/01/1985
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
-
-