KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)— 510(k) K924488

Clearance details

Applicant

Eastman Kodak Company

Product code

Code JIH

Device class

Class 2

Regulation

21 CFR 862.3560

Advisory panel

Clinical Toxicology

Date received

1992-09-03

Decision date

1993-01-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 1322001-06-07
• K934106 — KODAK EKTACHEM DTSC II SLIDES (LI)1994-04-25
• K921403 — MODEL 654 ANALYZER1992-07-30

• K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 65513862006-03-31
• K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE2006-03-16
• K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM2006-02-08
• K060055 — KODAK PACS2006-02-07
• K053347 — KODAK CARESTREAM PACS2006-01-04

• Z-1471-2017 — VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.Class II·Terminated·Ortho-Clinical Diagnostics·20170201
• Z-0316-2014 — VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration 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 K924488.