KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE— 510(k) K934413

Clearance details

Applicant

Eastman Kodak Company

Product code

Code CIT

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

1993-09-10

Decision date

1994-04-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL2007-10-03
• K071211 — COBAS C 111 ANALYZER2007-07-30

• 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-0299-2014 — VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated SystemClass 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 K934413.