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 Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
510(k) Number K934550
Device Name IMMUNOCARD MYCOPLASMA
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact ALLEN D NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact ALLEN D NICKOL
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received09/22/1993
Decision Date 09/20/1994
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
Recalls CDRH Recalls
-
-