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 Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K944664
Device Name WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
Applicant
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number862.1645
Classification Product Code
JIQ  
Subsequent Product Code
JIS  
Date Received09/22/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-