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 Quality Control Slides
510(k) Number K822604
Device Name ACID FAST QUALITY CONTROL SLIDES
Applicant
Medastat Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medastat Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2660
Classification Product Code
LJG  
Date Received08/27/1982
Decision Date 09/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-