The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control Lt, Liquichek Cardiac Markers Plus.
| Device ID | K050537 |
| 510k Number | K050537 |
| Device Name: | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne S Parsons |
| Correspondent | Suzanne S Parsons BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004264 | K050537 | 000 |
| 00847661000624 | K050537 | 000 |
| 00847661000617 | K050537 | 000 |
| 03610520865323 | K050537 | 000 |
| 03610520865316 | K050537 | 000 |
| 03610520865309 | K050537 | 000 |
| 03610520865293 | K050537 | 000 |
| 03610520865286 | K050537 | 000 |
| 03610520865279 | K050537 | 000 |
| 03610520865262 | K050537 | 000 |
| 03610520865255 | K050537 | 000 |
| 03610520865248 | K050537 | 000 |
| 03610520865231 | K050537 | 000 |
| 03610520865224 | K050537 | 000 |
| 00847661000631 | K050537 | 000 |
| 00847661000648 | K050537 | 000 |
| 00847661000709 | K050537 | 000 |
| 00847661004257 | K050537 | 000 |
| 00847661004233 | K050537 | 000 |
| 00847661004226 | K050537 | 000 |
| 00847661004219 | K050537 | 000 |
| 00847661004202 | K050537 | 000 |
| 00847661004196 | K050537 | 000 |
| 00847661004189 | K050537 | 000 |
| 00847661004172 | K050537 | 000 |
| 00847661001744 | K050537 | 000 |
| 00847661001737 | K050537 | 000 |
| 00847661000747 | K050537 | 000 |
| 00847661000730 | K050537 | 000 |
| 00847661000723 | K050537 | 000 |
| 03610520865217 | K050537 | 000 |