The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, And Cki/mbi Calibrator, Models Df38, Df32.
| Device ID | K081731 |
| 510k Number | K081731 |
| Device Name: | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CGS |
| Subsequent Product Code | JHS |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2008-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768025556 | K081731 | 000 |
| 00842768025549 | K081731 | 000 |
| 00842768025525 | K081731 | 000 |