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 Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K994438
Device Name BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
Applicant
SPECTRX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
SPECTRX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number862.1113
Classification Product Code
MQM  
Date Received12/30/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-