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 System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K933188
Device Name DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact RADAMES RIESGO
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact RADAMES RIESGO
Regulation Number864.5425
Classification Product Code
JPA  
Date Received06/30/1993
Decision Date 09/22/1993
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
-
-