KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN— 510(k) K941142

Clearance details

Applicant

Eastman Kodak Company

Product code

Code DIP

Device class

Class 2

Regulation

21 CFR 862.3350

Advisory panel

Clinical Toxicology

Date received

1994-03-10

Decision date

1994-06-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS2007-10-17
• K030428 — ROCHE ONLINE TDM PHENYTOIN2003-04-28
• K011393 — RANDOX PHENYTOIN2001-12-04
• K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A2292001-05-17

• 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-2344-2018 — VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnosticClass II·Terminated·Ortho-Clinical Diagnostics·20180509
• Z-0273-2018 — VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) 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·20170612
• Z-0202-2016 — VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.Class III·Terminated·Ortho-Clinical Diagnostics·20150928
• Z-0007-2015 — VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) 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·20140820
• Z-0321-2014 — VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) 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 K941142.