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 Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K864544
Device Name DIABETES RISK DETECTOR
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 Number862.1340
Classification Product Code
JIL  
Date Received11/19/1986
Decision Date 07/27/1987
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
-
-