FDA.reportPublic FDA data

Embrace Pro Control Solution (L1/Normal; L2/High)

Primary DI
00894030002413
Brand
Embrace Pro Control Solution (L1/Normal; L2/High)
Company
OMNIS HEALTH
Model
ALL02AB0210
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083628000GLUCODR AUTO SYSTEMAll Medicus Co., Ltd.2009-05-01NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002413008940300024138940300024130894030002413

Regulatory Flags#

DUNS number
023891520
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894030002345Embrace EVO Control Solution, L1 (Low)APX02AB08102016-08-23
00894030002352Embrace EVO Strips, 50ct Vial - RETAILAPX02AB08022016-08-23
00894030002376Embrace EVO Control Solution, L2 (Medium)APX02AB08112016-08-23
00894030002390Embrace Pro MeterALL01AB02002016-08-23
00894030002406Embrace Pro Strips, 50-ct vialsALL02AB02022016-08-23
00894030002420Embrace EVO Mini Meter, all-in-one kit, RETAILAPX01AB08512016-08-23
00894030002475EmbraceEVO Gestational Diabetes Package - SMALL (5 vials)APX01GS0100-S2016-08-23
00894030002482EmbraceEVO Gestational Diabetes Package - LARGE (9 vials)APX01GS0100-L2016-08-23
00894030002543EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials)APX01AGS0100-SR2016-08-23
00894030002017Embrace Meter, Meter OnlyAPX01AB2002016-08-23
00894030002024Embrace Strips, 50ct Vial - Distributor partnerAPX02AB02022016-08-23
00894030002062Embrace Control Solution, L2 (High)APX02AB03112016-08-23
00894030002079Embrace Control Solution, L1 (Low)APX02AB3102016-08-23
00894030002086Embrace Strips, 10-ctAPX02AB02002016-08-23
00894030002260Embrace Meter Kit (w/10 ct)APX01AB03002016-08-23
00894030002338Embrace Strips, 50ct Vial - Mail Order (Yellow Band)APX02AB0202MO2016-08-23
00894030002536Embrace Meter Value Pack (incl. 50ct)APX01AK0200VK2016-08-23
00894030002550Embrace Gestational Diabetes Package - SMALL (5 vials)APX01GS0200-S2016-08-23
00894030002567Embrace Gestational Diabetes Package - LARGE (9 vials)APX01GS0200-L2016-08-23
00894030002574Embrace Gestational Diabetes - Strips Refill Bundle (4 vials)APX02GS0202RF2016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730167Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730174Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730181Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00850011135921AccuTrakLgc Clinical Diagnostics, Inc.JJX2026-10-15
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956807Refractrol SP HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075957286Refractrol SP LowLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956791Refractrol SP 6.0 LowLgc Clinical Diagnostics, Inc.JJX2026-07-28
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
05060169690899IDS High Sensitive Estradiol Control SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169691087IDS Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169697218IDS High Sensitive Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLC DBA PIP DIABETES CAREJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02