The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Loci Cardiac Troponin-i Control (low), Lctni Con L.
| Device ID | K121084 |
| 510k Number | K121084 |
| Device Name: | LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Frances A Dillon |
| Correspondent | Frances A Dillon Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768037535 | K121084 | 000 |
| 00842768037528 | K121084 | 000 |
| 00842768037511 | K121084 | 000 |