MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR — Roche Diagnostic Systems, Inc. (510(k) K871680)
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR — Roche Diagnostic Systems, Inc. (510(k) K871680) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR; Applicant: Roche Diagnostic Systems, Inc.; Clearance track: 510(k).
| Device name | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR |
|---|---|
| Applicant | Roche Diagnostic Systems, Inc. |
| Clearance track | 510(k) |
| Submission number | K871680 |
| Decision | Substantially Equivalent |
| Decision date | 1987-06-08 |
| Date received | 1987-04-29 |
| Product code | LAN |
| Device class | 2 |
| Medical specialty | Clinical Toxicology |
| Applicant location | NJ, US |
| Source | openFDA device |
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