CHH

Product Code: CHH


Products Classified as CHH

313Enzymatic Esterase--oxidase, CholesterolCholesterol (total) Test System.

Total Product Life Cycle (TPLC) Devices

313Enzymatic Esterase--oxidase, CholesterolCholesterol (total) Test System.

FDA Consensus Standards

Enzymatic Esterase--Oxidase, Cholesterol [11555]21 CFR §862.1175 🔎

Pre-market Notifications for CHH

K203597Cholesterol2Abbott Ireland Diagnostics Division
K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.
K181373Extended Lipid Panel AssayLaboratory Corporation Of America Holdings
K180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.
K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON LABORATORIES INC.
K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPOLYMER TECHNOLOGY SYSTEMS, INC.
K150654CholesterolRANDOX LABORATORIES, LTD.
K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLAXIS-SHIELD POC AS
K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMABAXIS, INC.
K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K120202EON CHOLESTEROL REAGENTVITAL DIAGNOSTICS PTY. LTD
K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K111753HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDEHITACHI CHEMICAL DIAGNOSTICS, INC.
K091413S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)ALFA WASSERMANN, INC.

Global Unique Device Identification Database

00381931790018ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00381931782013ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00381931765016ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00381931711013ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00381930860019ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00380740132606ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00380740012861ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00365702276109Enzymatic Esterase--Oxidase, Cholesterol
00304040037713ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00628063400379ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00628063400362ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00628063400355ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
00657498001592Enzymatic Esterase--Oxidase, Cholesterol
00657498001141Enzymatic Esterase--Oxidase, Cholesterol
00657498000656Enzymatic Esterase--Oxidase, Cholesterol

Maude Adverse Events

CHOL2 CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2020-02-10
CHOL2 CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2019-09-17
CHOL2 CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2019-08-05
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2019-07-31
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2019-05-03
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2018-05-25
CHOL2 CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2017-12-14
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2017-11-06
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2017-10-30
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-10-17
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-10-16
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2017-10-11
COBAS 8000 C 502 MODULEROCHE DIAGNOSTICS2017-09-15
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2017-08-30
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2017-07-24
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-04-14
COBAS 4000 C (311) STAND ALONE SYSTEMROCHE DIAGNOSTICS2017-04-14
ADVIA CHEMISTRY XPTSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-03-31
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-03-13
DIMENSION XPAND WITH HMSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-03-01
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2017-02-15
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC2017-01-27
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-01-10
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2016-11-30
CHOLESTEROL REAGENT, CONCENTRATED (CHOL_C)SIEMENS HEALTHCARE DIAGNOSTICS INC.2016-11-15
CHOL2 CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2016-09-27
ACCUTREND CHOLESTEROLROCHE DIAGNOSTICS2016-04-26
CHOLESTEROL GEN. 2ROCHE DIAGNOSTICS2016-03-21
INTEGRA 800ROCHE DIAGNOSTICS CORP.2014-09-26
DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW2012-10-24
PRINTER, THERMAL, 110VALERE SAN DIEGO, INC.2012-10-24
CHOLESTECH LDXALERE SAN DIEGO, INC.2012-10-17
CHOLESTECH LDXALERE SAN DIEGO, INC2012-09-05
CHOLESTECH LDXALERE SAN DIEGO, INC.2012-08-10
LDX PRINTERALERE SAN DIEGO, INC.2012-06-21
AXIOHM PRINTER, UNIV W/ POWER SUPPLY ONLYALERE SAN DIEGO, INC.2012-05-25
PRINTER, THERMAL, 110VALERE SAN DIEGO INC2012-05-10
CHOLESTECH LDX NORTH AMERICAALERE SAN DIEGO, INC.2012-05-02
LDXPRINTER, THERMAL, 110VALERE SAN DIEGO, INC.2012-03-29
AXIOHM PRINTER, UNIV W/ POWER SUPPLY ONLYALERE SAN DIEGO, INC.2012-03-27
CHOLESTECH LDXALERE SAN DIEGO, INC.2011-12-20
CHOLESTECHALERE SAN DIEGO, INC.2011-12-20
SYNCHRON CHOLESTEROLBECKMAN COULTER, INC2011-11-15
CHOLESTECHALERE SAN DIEGO, INC.2011-09-15
CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2011-07-27
CHOLESTEROLROCHE DIAGNOSTICS2011-07-27
CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2011-06-20
CHOLESTECHALERE SAN DIEGO, INC.2011-06-17
CHOLESTEROL GEN.2ROCHE DIAGNOSTICS2011-05-23
LDXCHOLESTEROL METER POWER SUPPLYALERE SAN DIEGO, INC.2011-05-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.