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

Recognized Consensus Standards
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 021 Publication Date: 03/18/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-71: CLSI H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition. (InVitro Diagnostics)

Date of Standard: 2000. 
Address of Standards Organization:
  Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Devices that measure hemoglobin in blood
Processes Affected:
510(K), PMA, IDE, PDP
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.5200 Counter, Cell, Automated (Particle Counter) Class 2 GKL
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.5620 System, Hemoglobin, Automated Class 2 GKR
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.8165 Calibrator For Hemoglobin And Hematocrit Measurement Class 2 KRZ
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Josephine Bautista
  FDA/CDRH/OIVD
  2098 GAITHER ROAD, HFZ-440
  ROCKVILLE MD 20850
  240/276-0847
  Email: josephine.bautista@fda.hhs.gov
-
-