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 Assay, Glycosylated Hemoglobin
510(k) Number K930823
Device Name PROTEIN-BOUND GLUCOSE ASSAYN KIT
Applicant
Diagnostic Specialties
4 Leonard St.
Metuchen,  NJ  08840
Applicant Contact RINALDO PAGNUCCO
Correspondent
Diagnostic Specialties
4 Leonard St.
Metuchen,  NJ  08840
Correspondent Contact RINALDO PAGNUCCO
Regulation Number864.7470
Classification Product Code
LCP  
Date Received02/17/1993
Decision Date 08/19/1993
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
-
-