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 Solution, Copper Sulfate For Specific Gravity Determinations
510(k) Number K882101
Device Name HEMOGLOBIN SCREENING DEVICE
Applicant
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Applicant Contact WARREN R SANBORN
Correspondent
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Correspondent Contact WARREN R SANBORN
Regulation Number864.9320
Classification Product Code
KSL  
Date Received05/11/1988
Decision Date 07/01/1988
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
-
-