The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Ise Module And Bar Code Reader Addition For The Datapro Clinical Chemistry Analyzer.
| Device ID | K070531 |
| 510k Number | K070531 |
| Device Name: | ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | Thermo Fisher Scientific 171 INDUSTRY DRIVE Pittsburgh, PA 15275 |
| Contact | Bola Nicholson |
| Correspondent | Bola Nicholson Thermo Fisher Scientific 171 INDUSTRY DRIVE Pittsburgh, PA 15275 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-23 |
| Decision Date | 2007-09-04 |
| Summary: | summary |