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 Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K850218
Device Name SWIM'S S-77 POWDER MEDIUM
Applicant
HAZLETON RESEARCH PRODUCTS, INC.
BOX 7200
DENVER,  PA  17517
Applicant Contact JAMES K NOEL
Correspondent
HAZLETON RESEARCH PRODUCTS, INC.
BOX 7200
DENVER,  PA  17517
Correspondent Contact JAMES K NOEL
Regulation Number864.2220
Classification Product Code
KIT  
Date Received01/22/1985
Decision Date 03/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-