510(k) K922072 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
KODAK EKTACHEM 250 ANALYER
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Jul 10, 1992 |
| Received | May 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 250 Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 250 Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 250AT Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 350 Chemistry System, clinical chemistry analyzer Terminated |
JJE | None listed |
| Apr 8, 2019 | Ortho-Clinical Diagnostics VITROS 250 Chemistry System, Product Code 8132086,
(UDI # 10758750004409)
Product Usage:
Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include Terminated |
JJE | None listed |
| Apr 8, 2019 | Ortho-Clinical Diagnostics VITROS 250AT Chemistry System, Product Code 1758143,
(UDI # 10758750000036)
Product Usage:
Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include Terminated |
JJE | None listed |
| Apr 8, 2019 | Ortho-Clinical Diagnostics VITROS 250 Chemistry System Refurbished, Product Code 6801759,
(UDI # 10758750001330)
Product Usage:
Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologi Terminated |
JJE | None listed |
| Apr 8, 2019 | Ortho-Clinical Diagnostics VITROS 350 Chemistry System, Product Code
6802153, (UDI # 10758750002054)
Product Usage:
Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include Terminated |
JJE | None listed |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD.
Product Usag Terminated |
JJE | None listed |
| Mar 8, 2016 | Ortho-Clinical Diagnostics VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD.
Product Usage:
For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete Terminated |
JJE | None listed |
| Mar 19, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive Terminated |
CIG | None listed |
| Feb 25, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606
VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350 Terminated |
JIX | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180
VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/9 Terminated |
CJE | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034
VITROS CK Slides quantitatively measure creatine kinase (CK Terminated |
JHS | None listed |
| Mar 22, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITRO Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.