DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE— 510(k) K083465

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code CGS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2008-11-24

Decision date

2009-02-27

Decision

Substantially Equivalent

Clearance type

Special

Location

Newark, DE, US

• K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
• K182702 — SEKURE Creatine Kinase Assay2019-04-17
• K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator2016-09-07
• K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
• K112416 — CPK REAGENT2011-11-09

• K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more2025-04-25
• K162977 — ADVIA 2120i, ADVIA 21202017-08-11
• K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL2017-03-16
• K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)2017-03-09
• K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2016-11-17

• Z-1659-2018 — Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20170629

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083465.