KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)— 510(k) K812027

Clearance details

Applicant

Eastman Kodak Company

Product code

Code CIW

Device class

Class 2

Regulation

21 CFR 862.1070

Advisory panel

Clinical Chemistry

Date received

1981-07-20

Decision date

1981-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K931559 — DMA AMYLASE PROCEDURE1993-10-28
• K924339 — OLYMPUS AMYLASE REAGENT1992-10-19
• K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 656531989-01-11
• K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT1985-03-05
• K810584 — PHADEBAS ISOAMYLASE TEST1981-05-13

• 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-2364-2020 — VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.Class II·Terminated·Ortho-Clinical Diagnostics·20200511
• Z-2365-2020 — VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.Class II·Terminated·Ortho-Clinical Diagnostics·20200511
• Z-2366-2020 — VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.Class II·Terminated·Ortho-Clinical Diagnostics·20200511
• Z-2367-2020 — VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.Class II·Terminated·Ortho-Clinical Diagnostics·20200511
• Z-0298-2014 — VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine 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 K812027.