KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)— 510(k) K861387

Clearance details

Applicant

Eastman Kodak Company

Product code

Code JHS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1986-04-14

Decision date

1986-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• Z-0770-2021 — VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.Class II·Ongoing·Ortho Clinical Diagnostics Inc·20201211
• Z-1930-2020 — VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.Class II·Terminated·Ortho-Clinical Diagnostics·20200401
• Z-1931-2020 — VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.Class II·Terminated·Ortho-Clinical Diagnostics·20200401
• Z-0306-2014 — VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.Class II·Terminated·Ortho-Clinical Diagnostics·20130612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K861387.