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, Fibrinogen
510(k) Number K881150
Device Name KINETIC FIBRINOGEN ASSAY
Applicant
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Applicant Contact W EICHELBERGER
Correspondent
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Correspondent Contact W EICHELBERGER
Regulation Number864.7340
Classification Product Code
GIS  
Date Received03/17/1988
Decision Date 03/28/1988
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
-
-