The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Anti-mitochondrial Control, Positive, Catalog #127.
| Device ID | K024227 |
| 510k Number | K024227 |
| Device Name: | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661000198 | K024227 | 000 |