• 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 wright's stain
510(k) Number K760027
Device Name DSP - STAIN PACK
Applicant
HARLECO
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
HARLECO
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
IAF  
Date Received06/14/1976
Decision Date 07/20/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-