Atlas FDA

KHG

39 FDA 510(k) clearances · Product code

47 daysmedian time to decision
196 days90th percentile
39clearances measured

FDA profile

Official device name
Whole Blood Hemoglobin Determination
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7500
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AnemoCheck Home (K221508)Sanguina, Inc.2023-09-29
AnemoCheck (K163215)Sanguina, LLC2017-09-13
ANEMIAPRO SELF-SCREENER (K042379)Biosafe Laboratories, Inc.2004-12-15
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 (K020138)Gds Technology2002-02-11
CARESIDE HEMOGLOBIN (K001462)Careside, Inc.2000-08-21
HEMOSITE TEST SYSTEM (K994073)Gds Technology, LLC2000-01-14
HEMOSITE TEST SYSTEM (K973649)Gds Technology, LLC1998-08-31
ABBOTT VISION HEMOGLOBIN (MODIFICATION) (K953221)Abbott Laboratories1995-09-29
REFLOTRON HEMOGLOBIN TEST TABS (K934064)Boehringer Mannheim Corp.1993-12-06
BIOTRACK HEMOGLOBIN TEST CARTRIDGE (K895101)Biotrack, Inc.1989-10-10
CLINISTAT HEMOGLOBIN REAGENT TEST (K885227)Heraeus Kulzer, Inc.1989-02-24
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 (K880038)Sigma Diagnostics, Inc.1988-04-21
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 (K872653)Em Diagnostic Systems, Inc.1987-07-23
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD (K870363)Trace Scientific , Ltd.1987-03-16
TOTAL HEMOGLOBIN (K863104)J. D. Assoc.1986-09-04
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) (K862641)U. S. Diagnostics, Inc.1986-08-21
VISION(TM) HEMOGLOBIN (K862202)Abbott Laboratories1986-08-18
ERMA HB-METER MODEL 303N (K854687)Future Impex Corp.1986-06-04
HEMOGLOBIN REAGENT SET (K860475)Sterling Diagnostics, Inc.1986-03-03
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB (K854139)Eastman Kodak Company1985-11-05
HEMOGLOBIN ANALYZER (K851467)Awareness Technology, Inc.1985-07-16
HEMOGLOBIN (K851432)Pointe Scientific, Inc.,1985-07-12
EASYTOUCH HEMOGLOBIN REAGENT (K832750)Worthington Diagnostic Systems1983-09-26
CO-OXIMETER CONTROL (K831813)United Diagnostics, Inc.1983-07-28
REFEREE BRAND CO-OXIMETER REAGENTS (K830180)Analytical Products, Inc.1983-04-08
CORNING 2500 CO-OXIMETER (K830590)Corning Medical & Scientific1983-04-05
HEMOGLOBIN REAGENT (K823060)Biorent Diagnostic, Inc.1982-11-22
SERALYZER HEMOGLOBIN REAGENT STRIPS (K822044)Miles Laboratories, Inc.1982-07-30
SERALYZER HEMOGLOBIN TEST MODULE (K822045)Miles Laboratories, Inc.1982-07-30
HEMOGLOBIN REAGENT (K821658)Anco Medical Reagents & Assoc.1982-06-25
CYANMETHEMOGLOBIN TEST (K820596)Boehringer Mannheim Corp.1982-03-26
AMES SERA-PAK HEMOGLOBIN REAGENT (K803248)Miles Laboratories, Inc.1981-01-26
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT (K802268)R&D Systems, Inc.1980-12-31
ABNORMAL HEMOGLOBIN CONTROL (K802569)Marilyn L. Amick1980-11-12
HEMOGLOBIN CONTROL (K802568)Marilyn L. Amick1980-11-12
HEMOGLOBIN CONTROL LEVELS (K801268)Bioscientific1980-07-14
COMPUR M-1000 MINI-PHOTOMETER (K800059)Miles Laboratories, Inc.1980-04-04
SANDARE CYANMETHEMOGLOBIN REAGENT (K792503)Sandare Chemical Co., Inc.1979-12-31
OXIMETER, CO-, IL MODEL 282 (K760208)Instrumentation Laboratory CO1976-07-26

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Every clearance here is in the API, with alerts when new ones post.