FDA.reportPublic FDA data

510(k) K862202

Device
Vision(tm) Hemoglobin
Applicant
ABBOTT LABORATORIES
510(k) number
K862202
Product code
KHG
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-18
Date received
1986-06-10
Regulation
864.7500
Classification name
Whole Blood Hemoglobin Determination
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATT KLAMRZYNSKI
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221508AnemoCheck HomeSanguina, Inc.2023-09-29
K163215AnemoCheckSanguina, LLC2017-09-13
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