The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Loci 8 Calibrator, Model Kc 646.
| Device ID | K101460 |
| 510k Number | K101460 |
| Device Name: | LOCI 8 CALIBRATOR, MODEL KC 646 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna Marie Ennis |
| Correspondent | Anna Marie Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-26 |
| Decision Date | 2010-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768026492 | K101460 | 000 |