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 Counter, Differential Cell
510(k) Number K853304
Device Name 21 HEMATOLOGY REAGENTS
Applicant
IN VITRO DIAGNOSTICS, INC.
415 HOWE AVE.
SHELTON,  CT  06484
Applicant Contact JAY MININBERG
Correspondent
IN VITRO DIAGNOSTICS, INC.
415 HOWE AVE.
SHELTON,  CT  06484
Correspondent Contact JAY MININBERG
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/05/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-