The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Berichrom Heparin Uf Calibrator, Berichrom Heparin Uf Control 1, And Berichrom Heparin Uf Control 2.
| Device ID | K083175 |
| 510k Number | K083175 |
| Device Name: | BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Janet M Fose |
| Correspondent | Janet M Fose SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | JPA |
| Subsequent Product Code | GGC |
| Subsequent Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006869 | K083175 | 000 |
| 00842768006838 | K083175 | 000 |
| 00842768006821 | K083175 | 000 |