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 K990899
Device Name HEMOCHEK-A1C SAMPLE COLLECTION KIT
Applicant
OSBORN GROUP, INC.
14901 WEST 117TH ST.
OLATHE,  KS  66062
Applicant Contact GILBERT P BOURK III
Correspondent
OSBORN GROUP, INC.
14901 WEST 117TH ST.
OLATHE,  KS  66062
Correspondent Contact GILBERT P BOURK III
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/18/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-