The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak.
| Device ID | K100727 |
| 510k Number | K100727 |
| Device Name: | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons BIO-RAD, DIAGNOSTICS GRP. 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 | 2010-03-15 |
| Decision Date | 2010-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005148 | K100727 | 000 |
| 00847661005131 | K100727 | 000 |
| 00847661005124 | K100727 | 000 |
| 00847661005117 | K100727 | 000 |