FDA.reportPublic FDA data

510(k) K163215

Device
AnemoCheck
Applicant
SANGUINA, LLC
510(k) number
K163215
Product code
KHG  
Decision
Substantially Equivalent (SESE)
Decision date
2017-09-13
Date received
2016-11-16
Regulation
864.7500
Classification name
Whole Blood Hemoglobin Determination
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIKA TYBURSKI
Address
575 14th St. Atlanta GA US 30318 30318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221508AnemoCheck HomeSanguina, Inc.2023-09-29
K042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.2004-12-15
K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds Technology2002-02-11
K001462CARESIDE HEMOGLOBINCareside, Inc.2000-08-21
K994073HEMOSITE TEST SYSTEMGds Technology, LLC2000-01-14
K973649HEMOSITE TEST SYSTEMGds Technology, LLC1998-08-31
K953221ABBOTT VISION HEMOGLOBIN (MODIFICATION)Abbott Laboratories1995-09-29
K934064REFLOTRON HEMOGLOBIN TEST TABSBoehringer Mannheim Corp.1993-12-06
K895101BIOTRACK HEMOGLOBIN TEST CARTRIDGEBiotrack, Inc.1989-10-10
K885227CLINISTAT HEMOGLOBIN REAGENT TESTHeraeus Kulzer, Inc.1989-02-24
K880038FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527Sigma Diagnostics, Inc.1988-04-21
K872653EASY-TEST HEMOGLOBIN (HGB) ITEM #16685Em Diagnostic Systems, Inc.1987-07-23
K870363HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHODTrace Scientific , Ltd.1987-03-16
K863104TOTAL HEMOGLOBINJ. D. Assoc.1986-09-04
K862641U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)U. S. Diagnostics, Inc.1986-08-21

Legacy Summary#

summary

FDA Review#

Decision Summary