The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cardioimmune Xl Cardiac Marker Control.
| Device ID | K061196 |
| 510k Number | K061196 |
| Device Name: | CARDIOIMMUNE XL CARDIAC MARKER CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Scott Huntsman |
| Correspondent | Scott Huntsman MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-28 |
| Decision Date | 2006-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004399 | K061196 | 000 |
| 00884883002357 | K061196 | 000 |
| 00884883002364 | K061196 | 000 |
| 00884883002371 | K061196 | 000 |
| 00884883003606 | K061196 | 000 |
| 00884883003613 | K061196 | 000 |
| 00884883004368 | K061196 | 000 |
| 00884883004375 | K061196 | 000 |
| 00884883004382 | K061196 | 000 |
| 00884883002340 | K061196 | 000 |