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 Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K884058
Device Name COATEST PROTEIN C
Applicant
Kabivitrum, Inc.
1311 Harbor Bay Pkwy.
Alameda,  CA  94501
Applicant Contact G LEONARDI
Correspondent
Kabivitrum, Inc.
1311 Harbor Bay Pkwy.
Alameda,  CA  94501
Correspondent Contact G LEONARDI
Regulation Number864.7290
Classification Product Code
GGP  
Date Received09/26/1988
Decision Date 12/13/1988
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
-
-