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 Reagent, Occult Blood
510(k) Number K874180
Device Name COLORECTAL CANCER RISK DETECTOR (TM)
Applicant
Pearce Clinical Laboratories, Inc.
805 # San Jacinto
Conroe,  TX  77301
Applicant Contact PEARCE, PHD
Correspondent
Pearce Clinical Laboratories, Inc.
805 # San Jacinto
Conroe,  TX  77301
Correspondent Contact PEARCE, PHD
Regulation Number864.6550
Classification Product Code
KHE  
Date Received10/14/1987
Decision Date 09/30/1988
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
-
-